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.

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

July 10, 2018

Qserve Spotlight on Aibang Yuan

Interview with Qserve's Consultant Aibang Yuan
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.
July 04, 2018

Introduction Jasmin Hunter

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

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.  
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?