Our Services
By choosing Apotech for your auditing services, we can help you deliver complete regulatory compliance for all of your medical devices.
Practical solutions designed to deliver results
Adopt a risk-based approach to improve your quality and compliance.
At Apotech, our experienced consultants can help you improve the quality and compliance of your MedTech products. By taking a risk-based approach, we can help design and implement practical solutions that are proven to deliver results.
Adopting this scalable approach is also what allows us to work effectively with a wide range of companies – from research and develo
Our Global Reach
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Europe
Northern Europe
- Finland
- Latvia
- Norway
- Estonia
- Iceland
- Lithuania
- Sweden
Featured case studies
A genetic testing kit manufacturer Journey to UKCA Marking with Apotech
PathwayGen’s Journey to UKCA Marking with Apotech Introduction PathwayGen In response to the UK’s new post-Brexit regulatory requirements, PathwayGen, 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 Regulatory Strategy…
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…
Streamlining ISO 13485 Certification for a connected medical device
Streamlining ISO 13485 Certification for a connected medical device Introduction Our client is a startup at the forefront of connected health technology (diabetes) Types Quality Management System Implementation, ISO 13485 Certification Scope of work Apotech’s comprehensive support included a preliminary gap analysis, development and implementation of quality management systems tailored to the unique needs of…