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
Medical device CSV
Medical device CSV Introduction IVD manufacturer The client is an IVD manufacturer based in Europe. Although already ISO 13485:2016 certified, they were agnostic when it came to GAMP 5 and 21 CFR PART 11. They have 80 employees based over 2 sites in France. Apotech consultant: Apotech’s consultant coordinated 5 technicians, acting as project manager…
Tech Transfer
Tech Transfer (COVID-19 Vaccine) Introduction Worldwide Vaccine Manufacturer British-Swedish multinational pharmaceutical and biotechnology company. Areas Oncology, cardiovascular, gastrointestinal, infection, neuroscience, respiratory, and inflammation. Apotech Consultants The Apotech Consultants were embedded in the client’s global TechOps team. This team consisted of ~50 people, spread across the globe, and our consultants reported to the Director of Global…
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…