Clinical and Post-Market Services
Demonstrate complete regulatory compliance by ensuring your Medical Device conforms to all applicable global requirements.
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.
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.
Featured case studies
EU-MDR Technical File Authoring
EU-MDR Technical File Authoring Introduction Medical Technology Client Our client is a leader in high-quality, surgeon-designed, innovative ophthalmic products located in the US with operations globally. These range from Class I through to Class III devices. Apotech Consultants Our consultants take a risk-based approach to improve quality and compliance, and implement practical solutions for your…
A genetic testing kit manufacturer Journey to UKCA Marking with Apotech
Introduction The client In response to the UK’s new post-Brexit regulatory requirements, our client, an innovative genetic testing kit manufacturer, collaborated with Apotech to achieve UKCA marking. This strategic move was aimed at maintaining their market presence in the UK, ensuring uninterrupted access for their cutting-edge products. Types Scope of work Apotech provided end-to-end support…
510(k) Submission
510(k) Submission Introduction Radiographic Dental Imagery Device – Class IIb Our client are a leading manufacturer of radiographic dental imaging systems, based in Europe. Following European success, our client set their sights on the US market. Standards & Tools FDA 21 CFR Part 820 GDPR Word Excel, Powerpoint Scope of work Review of documentation for…