July 10, 2018

Qserve Spotlight on Aibang Yuan

Interview with Qserve's Consultant Aibang Yuan
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July 09, 2018

CFDA overseas inspection rapidly ramping up in numbers and expectations: are you prepared?

Most countries have enjoyed large gains in life expectancy over the past decades, thanks to advances in medicine. In China, life expectancy at birth has increased by more than 30 years since 1960, to reach 75.7 years in 2017. Today, China’s population is equivalent to 18.54% of the total world population, making it the most populated country in the world.
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July 04, 2018

Introduction Jasmin Hunter

We are very pleased to introduce Jasmin Hunter as a new member of our Qserve global team. 
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June 29, 2018

EMA guidance based on hard Brexit: impact for medical devices

With only 10 months to go, the world is gearing toward action in the light of the possible Brexit scenarios. At this time where first announcements of potential withdrawal from UK are being made by industries that rely on just-in-time delivery of parts to keep the costs down (e.g. airline, automotive), the authorities are shifting gears as well. That is obvious when reading the EMA guidance to industry in relation to Brexit updated last week.

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June 27, 2018

Hot off the presses!

FDA’s newest Guidance document: Recommended Content and Format of Test Reports for Complete Non-Clinical Bench Performance Testing in Premarket Submissions - Draft Guidance for Industry and Food and Drug Administration Staff; May 31, 2018, isn’t really “new news” but certainly formalizes the expectations FDA has had for test reports for many years.  
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June 27, 2018

Did you know that FDA is willing to fill in some voids?

Do you have questions about your laboratory testing to show substantial equivalence to a predicate device?
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June 27, 2018

Understanding FDA’s requirements for US Agent Representation

Interpreting FDA’s requirements for US Agent representation can be a daunting task… but Qserve Group US, Inc. can assist manufacturers with navigating this process.
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June 27, 2018

What progress has FDA made with its FY18 priorities?

Eight months into FDA’s FY2018, let’s look at the progress they have made in achieving their guidance document issuance goals. CDRH published the guidance document prioritization list it intends to work from in FY18 
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June 25, 2018

Qserve Spotlight on Jennifer Hadfield

Interview with Qserve's US Agent Representative & Office Manager, Jennifer Hadfield
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June 18, 2018

The REALITY of the EU-MDR timelines are sinking in

Gearing towards summer, the last key conference on EU-MDR was held last week in Brussels: the MedTech week hosted together with Informa and MedTech Insight. A significant portion of the event was focusing on the impact of the new EU-MDR and on exchanging views on how to solve the many unclarities and impossibilities.
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June 11, 2018

Qserve Spotlight on Nadira Salah, Quality Team Member

Interview with Qserve's consultant Nadira Salah

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June 07, 2018

Qserve expands global presence in MedTech with German office

PRESS RELEASE - June 7th, 2018
 
Qserve, the leading European medical device and IVD consultancy group, has opened a German office.
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June 06, 2018

The 4th edition is nearly there: EMC testing for medical devices – are you prepared?

In both the US and the EU by the end of 2018 application of the 4th edition of IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests are mandatory.
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June 04, 2018

Clinical investigation of medical devices for human subjects - Good clinical practice (GCP)

Good Clinical Practice (GCP) is a well-known and important quality concept in clinical trials.
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May 29, 2018

Boao BMTPZ provisional rules for import device published

In response to the State Council’s announcement on suspending the implementation of the article 11, paragraph 2 of “the Supervision and Administration of Medical Device regulation” (Order 650), the Hainan provincial government introduced “the provisional rules for the administration of import medical device in urgent need of clinical use”

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May 28, 2018

Qserve Spotlight on Femke Valkenburg, Clinical Team Member

Interview with Qserve's consultant Femke Valkenburg
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May 25, 2018

GDPR (EU) 2016/679: Records of processing activities for micro, small and medium-sized enterprises

In the last few days, just before the GDPR came into force (today May 25th, 2018), a lot of debate was going on about GDPR compliance for Small and Medium-sized Enterprises (SME’s).
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May 16, 2018

Key Challenges provided by the MDR for small and medium size enterprises

Medical device and diagnostics manufacturers are likely to face huge challenges to implement the new requirements imposed by the new European Medical Device Regulation.
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May 16, 2018

Interview with Stefan Menzl: Opening new office in Germany

Qserve will open a Germany office in June 2018, located in Karlsruhe and will be represented by Dr. Stefan Menzl who is a member of Qserve’s global team since October 2017. 

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May 14, 2018

Stay up-to-date with Qserve news!

Did you miss one of our newsletters? Here you can see the archive.

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April 26, 2018

The Medical Devices Regulations (MDR) in Germany

The new EU Medical Devices Regulation has been implemented in May this year. All manufacturers that plan to launch new products in Europe, have to expect dramatically increased requirements. The new regulatory scheme has a huge impact, especially for small and medium-sized enterprises.
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April 25, 2018

Facts and Figures: German MedTech market

Germany has the largest medical device market in Europe and third largest in the world after the United States and Japan. 
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April 25, 2018

Qserve Spotlight on Ashwini, Regulatory Team Member

Interview with Qserve's consultant Ashwini Kulkarni

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April 12, 2018

Luctor et Emergo – a Canadian solution for the MDSAP implementation

The fact that Canada will depend only on the MDSAP program to cover their Regulatory QMS requirements after the end of this year is causing great challenges and issues for medical device manufacturer.
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April 11, 2018

Qserve Spotlight on Samuel Golub, Regulatory Team Member

Interview with Qserve's consultant Samuel Golub
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April 09, 2018

"Boao" a shortcut for innovative devices to enter into China?

BFA (Boao Forum for Asia Annual Conference) of 2018 is taking place as planned from April 8 to 11. On the first day of the forum, the State Council - China’s cabinet - announced the decision on suspending the implementation of the article 11, paragraph 2 of “the Supervision and Administration of Medical Device regulation” (Order 650) in the special area BMTPZ (Hainan Boao Lecheng International Medical Tourism Pilot Zone) for those devices with urgent need and without equivalent device within China.
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April 05, 2018

Update on China's MDR Order. 650

CFDA is asking public to comment revisions to China’s Medical Device Regulation Order. 650 in early November 2017, and would like to finalize it in 2018. Order. 650 sets the fundamental regulatory requirements and guidance for medical devices in China throughout their lifecycle.
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April 04, 2018

The new Silk Road – One Belt, One Road

Rollercoaster in regulatory science, that is perhaps how I could best describe the road to regulatory compliance in China for medical devices. 
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April 03, 2018

Qserve team continues to grow!

To further strengthen our growing team of experts and increase our presence in Europe and the US, Qserve is pleased to welcome several new colleagues.
 
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March 30, 2018

Traceability - 2018 focus of CFDA innovative supervision approach

Premier Li Keqiang delivered the Government Work Report on March 5 during the annual plenary session of NPC (National People’s Congress), which reviewed the government work during the past 5 years and also shared the objectives of 2018. 
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March 28, 2018

Looking back on PMS and PMCF Webinar with ORCA

The sold-out webinar on PMS and PMCF under the MDR 2017/745 with the Organization of Clinical and Regulatory Associates (ORCA) on March 14, 2018 was a lively and detailed discussion.
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March 05, 2018

GDPR (EU) 2016/679: the application of Data Protection for manufacturers in the medical device industry

The General Data Protection Regulation (EU) 2016/679 is ratified and will take effect in May 2018. Is your organization ready to avoid heavy fines and loss of reputation resulting from non-compliance to the GDPR?

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March 05, 2018

Highlights and Challenges of the EU Medical Device Regulations

Medical device and diagnostics manufacturers are likely to face huge challenges to implement the new requirements imposed by the new European Medical Device Regulation.
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March 01, 2018

The IVDR – implementation debates starting ahead of the GAP assessments

Interesting developments in the IVDR field, as the approach taken by companies often deviates from the approach by companies working towards MDR compliance. And there is some logic to it.

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March 01, 2018

IVDR; how to anticipate the chaos?

The Regulation entered into force on May 26th, 2017, giving manufacturers five years to transition to the new IVD Regulation. The new rules will apply from May 2022 for IVD devices.
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February 15, 2018

Will ANVISA’s acceptance of ISO13485 certification be the end of MDSAP?

October 2017, ANVISA, the Brazilian regulatory authority, published resolution RDC no. 183 stating that for medical device manufacturers located outside the Brazilian territory and Mercosur, a different approach regarding granting of Good Manufacturing Practices (GMP) will be taken.
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February 12, 2018

18th RAPS Netherlands Chapter meeting

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February 06, 2018

The Brexit Challenge: Truth or Dare?

As the month February moves on, we see a storm in the news on the Brexit challenges and opportunities Do we still have time to sit back and relax? Or do we agree with Raphael Hogarth in yesterday’s Times that “it will soon be too late to salvage the Brexit trade talks”?
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February 05, 2018

US FDA and EU IVDR diverging in regulatory approach towards genetic testing

With the newly EU IVDR just published and with the US FDA interpretation on current legislation maturing, it is time to reflect on the direction authorities are taking towards genetic testing. On first review, it is clear that there will continue to be significant differences between FDA’s application of US laws and regulations and those of the EU in vitro Diagnostics Regulation (EU 2017/746). 
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February 01, 2018

What are the effects of the European MDR on Chinese Medical Devices manufacturers?

The new EU-MDR has been published on May 5, 2017 and will come into effect on May 26, 2020. This new Regulation is more explicit than the current legislation, which means that the Medical Device sector will need to increase its general level. 
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January 29, 2018

What to expect in 2018 for the MedTech sector

As we have come back from our Christmas break and started our work in the new year again, I want to take the opportunity in this blog to look ahead at what 2018 might bring us and what we need to prepare ourselves for. The MedTech sector awaits another year full of challenges and adjustment, especially considering the dynamic regulatory environment in Europe.

 

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January 18, 2018

How cyber security: system and data protection for medical devices will help you prepare for the upcoming EU-GDPR!

The daily news on cyber-attacks and system vulnerabilities have become overwhelming. Recently, the US FDA decided to force a recall on a pacemaker. The firmware of the device in question was found to be vulnerable to cybersecurity exploits, which could allow an unauthorized user to access a patient's device using commercially available equipment. 
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January 15, 2018

Time to put your hand on the plough!

Hard work, to change the barren land into the fertile soil from which we may later reap the fruits and veggies. That is what the 2018 year will bring us for EU MDR compliance. We’ve fed the horse and we’ve prepared the plough, made it sharp with our gap assessments, and perhaps some strategic rationales.
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January 12, 2018

Looking back on PMCF Webinar

During the Qserve webinar on 7 December 2017, Dr. Bassil Akra from TÜV SÜD, Wiebe Postma and Loes Pelgrim from Qserve gave a comprehensive overview of the requirements for Post-market clinical follow up (PMCF) under the new EU medical device regulation (MDR).
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January 02, 2018

Looking back on Qserve's MDR advanced training course in 2017

On December 11, Qserve organized the final session of the 2017 MDR advanced training course, that consisted of 10 separate events, one day per month. The final session was a full day open panel discussion with the Notified Bodies.
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December 21, 2017

Ending an important year in European medical device regulations

Now that we are approaching Christmas and prepare for the holidays, it’s time to look back on 2017
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December 18, 2017

How are manufacturers paying for Notified Body struggles?

The increasingly challenging environment, that EU notified bodies find themselves operating in, is translating into some real headaches for device and diagnostics manufacturers. 
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December 15, 2017

The commission has published a new version of the borderline manual

The most remarkable is the classification decision on a cardiac bypass procedure related cannula, that after decades of discussions are now classified as class III products.
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December 12, 2017

European NBOG Designation Codes for Notified Bodies are officially published

“These codes have been long-awaited, as they form the basis of the notified body designation under the new EU MDR and EU IVDR,” Gert Bos, executive director.
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November 28, 2017

What is the impact of the General Data Protection Regulation (GDPR) and the EU-MDR on medical devices that process personal data?

Since the increasing connectivity (Internet of Things) of medical devices over IT-Networks, like cloud solutions and the rapid integration and use of software applications (standalone or integrated), data protection is an essential requirement to preserve patient safety.
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November 13, 2017

Interview with Inette Nieveen on the effects of the Medical Device Regulation in Europe

In this interview, she will share with us the opportunities and challenges within the EU-MDR.
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October 02, 2017

Qserve continues to grow!

To further strengthen our growing team of experts and to increase presence in the US and in Europe, we are happy to introduce a few colleagues who joined our team in the past few months.

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September 12, 2017

Do you have sufficient clinical evidence for future EU-MDR compliance?

This blog looks at the impact of the new regulation on clinical studies you already performed, and clinical data you collected under the MDD, and challenges everyone’s decision to not perform additional clinical trials or PMCF studies.

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August 28, 2017

Interview with Inette Nieveen on the Medical Device Regulatory changes in Europe

To help you understand the impact of the EU MDR, we have asked one of our experts to share her first experiences from a Regulatory consultant’s perspective, and therefore, we have set up an interview with Inette Nieveen. She has been involved in complex MDR implementation projects and is able to identify critical bottlenecks in the process. 

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August 21, 2017

Consultation process under the new MDR - Is there anything new under the sun?

An increasing number of medical devices requires a consultation process under the new EU-MDR. Only then, an EU technical documentation assessment certificate can be issued for the device. 
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August 16, 2017

An EU-MDR question from a customer, Keith Morel shares his extended answer.

As an EU-MDR expert, we are always willing to answer questions and share knowledge about the EU-MDR. This time, Keith Morel, VP Regulatory Affairs, gives an answer to a question about the use of Harmonized Standards in Clinical Evaluations, which might be interesting for all medical device manufacturers.

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July 25, 2017

Funneling the bottlenecks! – The quest for clarity

So, what is everybody up to these days? Scheduling a family summer break or frantically working on the MDR project? Most important before you leave your laptop and find some quiet reading spot on a beach with a nice view, is to ensure you have funneled the bottlenecks you have so far identified into the clarification machines in Europe.
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July 11, 2017

Five reasons to start your MDSAP readiness now!

For a long time GHTF and its successor IMDRF have focused on providing guidance and harmonization. But recently they have moved to the next level of harmonization in practice. The first project is the so-called MDSAP program, the Medical Device Single Audit Program. 
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July 05, 2017

Qserve team is growing and expanding!

To further strengthen our growing team of experts and to increase presence in Europe and US, we are happy to announce a few colleagues who joined our team in the past half year.

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June 26, 2017

Ready for the Tyvek Transition?

Imminent start needed as ‘Legacy Tyvek’ might be running out of stock.
Three years ago, DuPont announced new production lines for the production of “Transition” Tyvek (type 1059B and 1073B).

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June 15, 2017

FDA UDI – Class I deadline extended

At the beginning of this month (June 2, 2017), FDA has issued a letter to medical device labelers related to adjustments in the compliance deadlines for the Unique Device Identification (UDI) System.
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June 07, 2017

An EU-MDR compliance check? With the Qserve EU-MDR First Aid app it is done quickly

To provide you some first aid in the lengthy process of MDR implementation we designed the EU-MDR First Aid App.
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June 01, 2017

Albert Koster, an experienced Quality Management expert joins Qserve as Senior Consultant.

It is with pleasure that we introduce Albert Koster as a member of our expanding team of experts. Albert brings experience in Quality Management Systems and Quality assessments and will join us to strengthen the Quality Assurance Business area.
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June 01, 2017

China CFDA 2016 annual report on Medical Device Registration

The 2016 annual summary report on Medical Device Registration in China is out!

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May 29, 2017

EU UDI - new requirements on medical device traceability

Following the global trend in handling the traceability of medical devices, the EU Commission has clearly defined the requirements for implementation of a Unique Device Identification (UDI) system.
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May 18, 2017

EU-MDR and EU-IVDR are live!

On the 5th of May 2017, the long awaited European Medical Device Regulation was published. The EU-MDR will affect all Medical Device manufacturers. Gert Bos shares his knowledge on this matter: Key changes with EU-MDR and EU-IVDR, Some Things to Expect During the Transition Period and Steps to Begin Taking Now.
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May 15, 2017

The first EU-MDR app by Qserve that gives insight into the compliance status is now available

Qserve designed a dedicated app that can be used as a tool to assess a company’s EU MDR implementation status and provide next steps on the road to compliance. 
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May 05, 2017

On your Marks! The countdown has begun

Today marks yet another milestone in the EU-MDR development: the day on which the EU-MDR and EU-IVDR are being published, with 20 days to go until the day of entry into force, and a total of 1116 days for the date of application of the MDR and 1847 days for the IVDR. 

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May 01, 2017

Founder Qserve Group Willibrord Driessen completes transition to new leadership

QserveÒ Group, a leading consulting group in medical device compliance, today announced the completion of the transition to new leadership for the company.

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April 12, 2017

Entering the Twilight Zone for legacy products

With the final steps of the approval of the new EU-MDR and EU-IVDR being moments away, the debates are moving to understand the impact and ramifications of the hard and soft transitioning specifications.

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April 03, 2017

A comparative view on medical device regulations

"When West meets East"-a Qserve article- is featured in Law View Partners' quarterly newsletter!

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April 03, 2017

How to confirm a combination product to regulations in the US?

Companies who market or want to market a combination product in the US face specific challenges to get and keep their products regulatory compliant. Although no new requirements are added, the scope for conforming with the requirements has changed.
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April 01, 2017

Is your medical device hacker proof?

Echoing the rapid development in the ICT sector, increasingly medical devices utilize the internet to enable electronic exchange or remote control of medical device related health information.
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April 01, 2017

Are you capable of answering the Notified Body questions on EO sterilization validation?

Notified Bodies raise expectations regarding sterilization processes and controls

 

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April 01, 2017

Unveiling the Masterpiece

Today marks yet another milestone in the EU-MDR development: the painters have been working diligently in the last weeks on the legal-linguistic balancing of the wording, and the final brush strokes have been placed.
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April 01, 2017

CRO selection a hurdle? Not with these tips to support a smooth selection process.

Outsourcing all -or some- of your clinical trial activities to a contract research organization (CRO) can have large advantages.

 

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February 13, 2017

Announcing Gert Bos as member of the RAPS Board of Directors

We are pleased to announce the appointment of Gert W. Bos, PhD, FRAPS, executive director and partner at Qserve Group as a new member of the RAPS Board of Directors.
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January 25, 2017

First EU MDR workshop was a success and all speakers for the February Clinical session are confirmed

On the 16th of January, 2017 the first Qserve EU MDR workshop took place in Amsterdam, The Netherlands. We were very pleased with the positive responses that were submitted through evaluations.
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January 24, 2017

Wiebe Postma, an experienced Clinical researcher joins Qserve Clinical team

It is with pleasure that we introduce Wiebe Postma as a member of our expanding team of experts. Wiebe brings experience in clinical evaluation and clinical investigation (CRO) and will join us to strengthen the Clinical Evaluation Business area, supporting also the growing need for clinical data in the field.
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January 23, 2017

Qserve expands its clinical services by offering Clinical Investigation (CRO)

The regulatory requirements regarding Clinical Evaluation have become more strict and prescriptive under the MEDDEV 2.7.1/ rev 4 and the new Medical device regulation in the EU.
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January 19, 2017

Mindy McCann, an experienced Regulatory Compliance expert joins Qserve as a Principal Consultant

To futher strengthen our growing team of experts and increase presence in the US, Qserve is happy to welcome Mindy McCann to its team. Mindy brings many years of industry and Notified Body experience  in Regulatory Compliance, Quality and Clinical.
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January 01, 2017

Interview with René Schings on MDSAP

MDSAP is being deployed for five countries, i.e. Canada, the United States, Brazil, Japan and Australia, with Canada really being on the forefront. However, in the rapidly changing regulatory environment, it is hard for manufacturers to remain properly informed. 
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December 22, 2016

Christmas Greetings

On behalf of the Qserve Group team, we would like to wish you a Merry Christmas and a Healthy 2018!

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December 05, 2016

EU MDR and EU IVDR getting closer to publication!

Following the approvals on the legislative proposals on both EU-MDR and EU-IVDR, the summer period has been utilized to translate the final draft that was agreed upon in principle into all EU languages. In August, a revised consolidated draft was released, and another version with first minor tweaks was circulated in the middle of October. 

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November 17, 2016

MEDICA 2016: International world of Medical Device innovation and market access

The MEDICA, the largest European trade show for medical device manufacturers, is an international meeting point for the professionals in the medical Device industry.
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November 08, 2016

Loes Pelgrim, an experienced Clinical researcher joins the Qserve Clinical team

It is with pleasure that we introduce Loes Pelgrim as a member of our fast expanding team of experts in Europe, US and China.
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November 07, 2016

Experienced Quality Assurance & Audit Manager Henk-Willem Mutsaers joins Qserve team

To further strengthen our growing team of experts and to increase presence in Europe and US, Qserve is happy to welcome Henk-Willem Mutsaers to its team.
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November 04, 2016

Jane Liang, MD joins Qserve’s Clinical team in China

Jane will be part of Qserve’s local Chinese team and from there strengthen the global Clinical Evaluation team, headed up by Dr. Anna Pietersma, in the position of Senior Consultant.
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October 04, 2016

Reduction in clinical trial burden in China

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September 21, 2016

China Business Development and Sales expert, Minghua Chen, joins Qserve Group

To further strengthen its fast growing team and to increase the growth in China, Qserve is happy to welcome Minghua Chen to its team. Minghua brings 13 years of professional experience in sales, marketing and business development in medical device industry to the Qserve Group.

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September 02, 2016

Usability Engineering for medical devices

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August 08, 2016

Declarations of Interest for Clinical Evaluators – what will be sufficient to meet the requirements

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July 14, 2016

MHRA uses 're-manufacturing' as interpretation for reprocessing

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July 11, 2016

China publishes draft of a third special fast track ‘green’ approval route

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June 29, 2016

Dutch minister thanks the Dutch delegation for reaching a compromise agreement

Earlier today the Dutch minister of Health and Labour, Mrs. Edith Schippers, thanks the members of the Dutch delegation that were behind the successful closure of the trilogue debates. She focused in her speech on the teamwork and great efforts displayed by the relative small group of staff, and supporting experts from various Dutch institutes.
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May 27, 2016

Revised Guidance Document for Clinical Evaluation in the EU [MEDDEV 2.7.1 (rev 4)]

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