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
Breakthrough Program
Breakthrough Program Introduction IVD manufacturer The company is a highly innovative IVD manufacturer start-up. Their device is CE marked and the client was looking to obtain FDA approval for sale on the US market. Apotech Consultants One consultant worked part-time on the project. The main focus was to design the rationale to be eligible for…
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…
Global in-country regulatory support
510(k) Submission Introduction Top 3 Global CRO Our client is one of the largest CROs globally, with operations present in every economy. Their services range from Clinical Development, Medical Affairs, and Commercial Delivery. Apotech continues to partner with them on a 3-year FSP contract. Apotech’s Consultants Our 18 strong Consulting team includes a mixture of…