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.

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

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.
April 11, 2018

Qserve Spotlight on Samuel Golub, Regulatory Team Member

Interview with Qserve's consultant Samuel Golub
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.
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.
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. 
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.