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). on May 24th for example, the Dutch minister Sander Dekker of the ministry for Judicial Protection, commented on the matter trying to settle some of the confusion, stating that small organization should not worry too much about the AP standing on the doorstep on the 26th of May and issuing fines to these SME’s.

Your Global Medtech Partner for Regulatory, Clinical & Quality Compliance

Qserve is the largest consultant company in the EU that is 100% focused on medical devices and In-Vitro Diagnostics. Check out our company video.

Regulatory Affairs

Regulations vary depending on the medical device and market you wish to enter. Our specialized teams will help you comply with all necessary regulations.

Clinical Affairs

Experience a practical approach based on your existing regulatory data. Our team supports medical writing of clinical evaluations (MEDDEV 2.7.1.), as well as full-service CRO activities.

Quality Assurance

Ensure that all quality performance requirements are met by implementing and maintaining a Quality Management System (QMS) based on local requirements.

Why choose Qserve as your regulatory consultant?

 

  • We know exactly what should be prepared to become and stay in compliance with the regulations
  • Strong international team with technical, regulatory quality and clinical competence.
  • Ex EU Notified Body, FDA, and CFDA staff.
  • Full Medical Device CRO services
  • We have a team where we use multiple levels, from junior to principal. Depending on your project we are able to form a cost-effective team.
  • We charge you for the work performed, no hidden costs.
  • We train and we leave something behind, a regulatory compliance imprint.
  • 1 contact point giving you access to a broad team with all expertise.
  • Legal representation in China, Europe and United States

 

Our method

"Our mission is to support all medical device manufacturers with a practical approach, translating existing regulations to understandable requirements."
Jan van Lochem , CEO

News

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). on May 24th for example, the Dutch minister Sander Dekker of the ministry for Judicial Protection, commented on the matter trying to settle some of the confusion, stating that small organization should not worry too much about the AP standing on the doorstep on the 26th of May and issuing fines to these SME’s.
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.
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. 

May 14, 2018

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April 26, 2018

The Medical Devices Regulations (MDR) in Germany

‚ÄčThe 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.
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.