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Clinical and Post-Market Services

Q: How does the European medical devices regulation (MDR 2017/745) impact CER requirements?

The MDR 2017/745 and revised CER guidance (MEDDEV 2.7/1 rev 4) both reflect more stringent requirements for clinical data and post-market requirements, highlighting the importance of ensuring your documentation is all in order. You will also need to update your CER on an annual basis. So get in touch with our team if you would like any additional support on this

Demonstrate complete regulatory compliance by ensuring your Medical Device conforms to all applicable global requirements.

CEP

CER

PMS

PMCF

Clinical Trials Consulting

Navigating the complexities of clinical evaluation and compliance

Trust Apotech for expert clinical support

At Apotech, we offer comprehensive support to medical device manufacturers looking to navigate the complexities of clinical evaluation and regulatory compliance.

Our experienced team specialises in crafting meticulous clinical evaluation reports (CERs), developing robust clinical protocols and overseeing clinical trials tailored to meet the unique needs of each project.

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Trusted by top-tier teams worldwide

Why choose Apotech for MedTech clinical and post-market services?

From conducting thorough literature reviews to designing clinical studies and analysing data, our team ensure that our clients receive expert guidance and support at every stage of the process.

Whether you're navigating the requirements of the EU MDR, FDA regulations or other global standards, our consultancy provides strategic insights and hands-on assistance to help you achieve regulatory approval and commercial success for your medical devices.

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FAQs on MedTech clinical and post-market services

At Apotech, we aim to make our MedTech clinical and post-market services as simple to understand as possible, which is why we’re always on hand to answer any questions you might have.

Here are some of the questions we get asked most often.

How does the European medical devices regulation (MDR 2017/745) impact CER requirements?

Featured case studies

Software as a medical device (SaMD)

Software as a medical device (SaMD) Introduction Our client designs and sells a CE marked Class IIa software, used in cardiology as a digital twin. Types Regulatory affairs Responsible person FSP Scope of work Our client recently partnered with groups of clinics in the United Kingdom and therefore asked us to act as their UK…

QMS Implementation for Class III Medical Device

QMS Implementation for Class III Medical Device Introduction Streamlining ISO 13485 Certification for a connected medical device. The company is a highly innovative start up, which has developed a best-in-class pacemaker. At the time of engaging with them they were on the road to CE Marking. Apotech Team Worked full time on the project: balanced…

Borderline device classification

Borderline device Classification Introduction Classification of borderline product (cosmetics VS medical device) Our client, a multinational cosmetics and wellness product manufacturer identified revenue opportunities marketing their cosmetics devices with increase claims. Apotech was engaged to perform a blanket regulatory assessment of cosmetic devices and provide judgement and pathways for market authorisation as a medical device…

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