June 17, 2019
Press release: Sue Spencer leading expert IVD joins Qserve

Qserve Group, the leading global medical device and in vitro diagnostics consultancy, training and CRO company, is welcoming Sue Spencer, further expanding its capabilities to support the IVD industry worldwide. Sue is the leading expert on EU IVD certification, having 35 years of IVD experience in industry and Notified Bodies.

Ihr globaler Partner im Bereich MedTech für Klinik, Qualität und Regulatory Compliance

Qserve ist das größte Beratungsunternehmen in der EU, das sich zu 100% auf Medizinprodukte und In-Vitro-Diagnostika konzentriert. Sehen Sie sich unser Firmenvideo an.

Europe

Our knowledge of the European Medical Device Regulation (EU-MDR) ensures that we can train and support you with an efficient regulatory strategy.

China

We can help you navigate through the Chinese market by offering a wide range of customized services.

USA

We have supported hundreds of Medical device manufacturers with FDA submission. Qserve’s legal entity can act as US Agent and Official Correspondent.

Warum Sie sich für Qserve als Regulatory Consultant entscheiden sollten

 

  • Warum Sie sich für Qserve als Regulatory Consultant entscheiden sollten
  • Wir wissen genau, was vorbereitet werden muss, um Compliance herzustellen und zu erhalten
  • Starkes internationales Team mit hoher Kompetenz im technischen, regulatorischen, qualitäts und klinischem Bereich
  • Mitarbeiter mit Berufserfahrung bei Benannten Stellen, FDA und CFDA
  • Kompetter CRO Service für Medizinprodukte
  • Unser Team besteht aus Mitarbeitern mit unterschiedlicher Seniorität und Erfahrung, vom Junior bis zum Direktor. Abhängig von Ihrem Projekt wählen wir eine kostengünstige Teamstruktur
  • Wir stellen Ihnen nur tatsächlich geleistete Arbeit in Rechnung. Es gibt keine versteckten Kosten
  • Wir führen Trainings durch und vermitteln ein tiefes Verständnis für Regulatory Compliance
  • Ein Ansprechpartner der Ihnen den Zugang zu einem eindrucksvollen Team von Experten
  • Legale Vertretung in China, Europa und den USA

Unser Konzept

"Es ist unsere Mission, alle Hersteller von Medizinprodukten auf pragmatische Weise zu unterstützen und bestehende Vorschriften in verständliche Anforderungen zu übersetzen." - Jan van Lochem, CEO."
Jan van Lochem , CEO

Neuigkeiten

Juni 17, 2019

Press release: Sue Spencer leading expert IVD joins Qserve

Qserve Group, the leading global medical device and in vitro diagnostics consultancy, training and CRO company, is welcoming Sue Spencer, further expanding its capabilities to support the IVD industry worldwide. Sue is the leading expert on EU IVD certification, having 35 years of IVD experience in industry and Notified Bodies.

Juni 14, 2019

China launches electronic registration system for medical device approval

China NMPAformer CFDArecently announced that the implementation of Electronic Regulated Product Submission system (e-RPS) will come into effect on June 24, 2019.  The format and arrangement of content stipulated are now part of the regulatory requirements to file for NMPA submission.

Juni 13, 2019

EU-MDR and EU-IVDR Booklets for sale in two convenients sizes

We are proudly introducing you our newest items. The Qserve MDR and IVDR in two convenient sizes. One for on your desk and one for in your bag. 
Juni 12, 2019

What Manufacturers Need to Know About China’s Overseas Inspections

China’s National Medical Products Administration (NMPA) has stepped up overseas inspections in recent years, and manufacturers looking to market products in China must be prepared for potential visits from Chinese inspectors. Gert Bos, PhD, FRAPS, executive director and partner with Qserve Group, addressed the topic during a session at the recent RAPS Regulatory Conference Europe in Brussels. Bos and his Qserve China colleague, Michael Yan, answered some questions about China’s inspections program in the following Q&A.

Juni 06, 2019

Interview with Gert Bos, Executive Director & Partner.

‘The situation regarding the delay in the designation of notified bodies under the new EU medical devices regulations is looking so critical that some member state competent authorities have even started discussing whether they should step in and assess the conformity of some of the products themselves’ 
Mai 28, 2019

The design and development process - beyond ISO 13485:2016 and MDSAP?

Earlier this month, Rania Gerges, a Qserve Consultant and a QMS expert presented “Beyond MDSAP and ISO 13485: The Impact of the New EU Regulations on Audits”, in the International Track at the MedCon conference in Cincinnati, OH. Rania focused her talk on how the MDR impacts the design and development cycle. This blog summarizes the main points of her talk.