Cookie Consent by Free Privacy Policy Generator

In Vitro Diagnostics and Medical Device Training

Regulatory Affairs, Quality Assurance and Clinical courses for Medical Devices and In Vitro Diagnostics

Medical Device and IVD Training

Practical Regulatory, Quality, and Clinical Medical Device Training

Qserve offers training programs in medical device and in vitro diagnostic regulations, aimed at assisting manufacturers with regulatory, quality, and clinical expertise at every level. Our trainings serve as a resource to keep your team updated with the latest information and to strengthen their regulatory knowledge.

Qserve Training sessions offer a dynamic and interactive environment, focusing on all compliance aspects of medical devices (MDs) and in vitro diagnostics (IVDs). We also offer tailored in-house training options to address the specific needs of your company. Our practical approach ensures that our training sessions are suitable for companies seeking to adapt to changing global regulations or to enhance their regulatory affairs (RA), quality assurance (QA), and clinical knowledge.

https://www.qservegroup.com/write/Afbeeldingen1/Testimonials/schings-quote (002).jpg?preset=content

Our training methodology integrates theory, hands-on learning experiences, and constructive feedback from experienced tutors. Additionally, participants have the opportunity to engage in discussions and learn from their peers, fostering a collaborative learning environment.

As a regulatory professional, your role is pivotal in guiding your organization through the various stages of the product life cycle. With the increasing complexity of Medical Device Regulations and In Vitro Diagnostic Regulations across different countries, it is crucial to equip your organization with the necessary regulatory knowledge. Qserve's training programs are tailored to meet these demands, ensuring that your team remains well-informed and adept in navigating regulatory requirements effectively.  

TRAINING

All training opportunities

MDR Suite

The European Medical Device Regulation (EU-MDR 2017/745), officially published on May 5, 2017, and enforced on May 25, 2017, mandates stringent requirements for medical device manufacturers and Notified Bodies involved in the approval process. With the transition deadline extended to May 26, 2021, all manufacturers of Class I to III medical devices must swiftly adapt to the new regulatory landscape. The EU-MDR introduces significant changes, including reclassifications, new conformity assessment routes, and heightened safety and compliance standards, affecting all classes of medical products.

Qserve offers comprehensive training covering every aspect of MDR implementation, equipping you with the necessary skills and knowledge for a smooth transition.

Our EU MDR Training options: 

  • EU Medical Device Regulations - The framework
  • Is your product a medical device?
  • Obligations of a Manufacturer and economic operators
  • Person Responsible for Regulatory Compliance
  • UDI
  • EUDAMED
  • The CE certification process
  • Select a Suitable Notified Body
  • What is the classification of your device?
  • Determine the regulatory pathway
  • Clinical Evaluation - Safety, Performance and Clinical Benefit
  • Clinical Investigation
  • PMS system
  • Vigilance
  • Governance Data protection
  • Transitional provisions
  • GSPR
  • Set up the Technical Documentation
  • QMS - Beyond the obvious
  • Custom made devices
  • PMCF
  • Products without an intended medical purpose

 

Contact our Training team

 

IVDR Suite

The In Vitro Diagnostic (IVD) industry is dedicated to designing products that deliver precise and dependable diagnoses for healthcare professionals and consumers. Strict regulations prioritize quality and safety during product development and market introduction.

Qserve's IVDR training is particularly interesting for professionals seeking to market their IVD in Europe. Our training covers all aspects of the IVDR, equipping you to navigate the transition from the IVD Directive (IVDD). Topics include classification, conformity assessment, CE marking, and labeling. We offer both online and classroom training options tailored to support IVD professionals. 

Our IVDR Training Options: 

  • IVD(R) customer journey
  • IVDR fundamentals
  • Preparing the QMS for the IVDR
  • Technical documentation for IVDR
  • Clinical evidence for IVDR
  • Performance Evaluation Studies and interventional studies
  • Risk Management to meet the IVDR
  • IVDR PMS and PMPF and how to implement the requirements
  • IVDR Software development process according to IEC 62304
  • CDx and Distance sales under the IVDR
  • Classification under IVDR & conformity assessment 
 

Contact our Training team

Clinical Suite (EU)

The MDR mandates robust clinical data to demonstrate the safety and efficacy of medical devices, essential for achieving CE marking. Moreover, ongoing clinical data collection post-market is essential to uphold patient safety standards.

Navigating through the regulations, guidance documents, and standards demands precise interpretation tailored to diverse device categories. Qserve presents a comprehensive virtual training program, designed to address manufacturers' clinical challenges. Delve into the latest requirements and guidance, ensuring a collection of important evidence for your medical device.

From clinical evaluation processes to investigations and post-market follow-ups, our sessions equip your team with the necessary expertise. Prepare your subject matter experts to implement these insights effectively within their specific areas of expertise through our specialized training sessions.

Our Clinical Training Options:

  • ISO 14155 Good Clinical Practice (GCP)
  • ISO 14155 GCP for investigators
  • Good Clinical Practice refresher training
  • Clinical evaluation
  • PMCF
  • PMCF Surveys
  • Design of Clinical Studies
  • Monitoring
  • Literature searches for Medical Devices
  • Literature searches for IVD

 

Contact our Training Team

US Regulations

Securing Food and Drug Administration (FDA) 510(k) clearance is essential for marketing medical device products in the United States. Therefore, medical device companies must carefully navigate the regulatory landscape to determine the optimal path for bringing their products to market. Understanding the requirements and timeline for completing the 510(k) process is crucial for successful submission and market entry.

Our US Regulations training options: 

  • 21 CFR 820 QSR
  • FDA 21 CFR Part 11
  • FDA Clinical Trial approaches
  • FDA Approvals
  • FDA Q-Submission

Contact our Training Team

China Regulations

Since the overhaul of the Chinese Medical Device Regulation in 2014, the regulatory landscape has undergone numerous updates, encompassing rules, technical guidance, and standards. To sell medical devices and in vitro diagnostics in the Chinese market, manufacturers must secure device registration with the National Medical Products Administration (NMPA).

A governmental reorganization has seen the integration of the former regulatory body, CFDA (China Food & Drug Administration), into the new CNDA (China National Drug Administration), signaling potential changes to the existing regulatory framework. The emergence of requirements such as clinical evidence, China Agents, and overseas inspections presents both opportunities and challenges for foreign medical device manufacturers.

Our China regulations training options:

 

Contact our Training Team

QMS & Auditing

In the medical device industry, having a quality management system is not only mandatory for manufacturers but also expected for other economic operators. However, setting up and maintaining such a system can give significant challenges, particularly for businesses lacking expertise in this domain. Our training program guides you through every phase of the process, helping you build, implement, and sustain a compliant and efficient quality management system. 

To ensure compliance of your quality management system before audits from our regulatory authorities or inspection bodies take place, your company must be well-prepared.

Our QMS and Auditing Training options

  • QMS/ ISO13485
  • Internal Auditing
  • Lead Auditor 
  • MDSAP
  • MDR internal auditing
  • Effective Supplier Control and Audits
  • Audit behavior (dos and don'ts)

Contact our Training team

Other Medical Device Training 

Ensuring consistent learning standards throughout your organization can be a challenging endeavor. It's crucial to guarantee that all personnel, both local and global, receive uniform and top-tier training. In addition to our MDR and IVDR Clinical Quality and Auditing training courses, we provide a range of in-depth courses covering specific topics to meet your organization's diverse needs.

Our Other training options:

  • Basics of global regulatory approval for medical devices
  • Market Access Beyond the EU and US Market
  • Introduction to Risk Management ISO 14971
  • Advanced Risk Management ISO 14971
  • Medical Device Software (incl. AI,SaMD, cybersecurity) IEC 62304, IEC/TR 80002, IEC 80001-1
  • Introduction Biological Safety Evaluation ISO 10993
  • Biological Safety of Medical Devices ISO 10993
  • Good documentation practices
  • Introduction to hazardous substances, e.g. RoHS, REACH
  • Basic Safety & Essential Performance, IEC 60601 
  • Usability IEC 62366-1
  • Biological Safety Evaluation
  • Combination products
  • Devices with animal tissue derivative, ISO 22442

Contact our Training team

Why choose Qserve as your Medical Device training provider?

Our comprehensive program offers training courses covering a diverse array of regulatory and clinical topics. Our expert staff delivers courses for professionals at all career stages. With offices in Europe, the US, and China, Qserve provides international expertise in medical devices and IVDs, ensuring tailored, high-quality training.

Our staff members possess both broad and specific expertise across a wide range of medical devices and IVDs, ensuring that you receive top-notch training tailored to your needs.

 

More information

Open Enrollment Training

For individuals seeking professional development opportunities in the fields of Regulatory, Quality Assurance, or Clinical, we offer an open enrollment program.

Visit our Events and Training page to discover our current and upcoming offerings. Our courses cover a wide range of topics, all designed to meet industry standards and stay abreast of the latest trends. Take the next step in your professional journey with Qserve's open-enrollment training courses. Explore new opportunities and elevate your career path.

 

Events & Training