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
Prosthesis manufacturer
Prosthesis manufacturer Introduction As part of their international development strategy, our client wanted to get MDSAP certified with a focus on Canada, Australia and Brazil. They were MDSAP certified within 7 months. Types MDSAP Audit Preparation, Quality Management System Review Scope of work Selecting the certification body (quotes, Q&A) Review of their quality management system…
Quarterly Internal Audits
Quarterly Internal Audits Introduction Quarterly Internal Audits Our client is a start-up medical device manufacturer of a body cooling device, for those with heat stroke. They are based in the UK and are undergoing ISO 13485 certification. Standards & Tools 21 CFR ISO 13485 MDSAP MDR Scope of work Key numbers Excited to work together…
Process and Test Method Validation Review and Improvement
Process and Test Method Validation Review and Improvement Introduction Cardiac Devices Our client is a leading manufacturer of Class III minimally invasive cardiac devices, based in Germany and selling to 85 countries worldwide. Apotech consultants Our consultants implemented a risk-based approach to improve quality and compliance, and implement practical solutions for the organisation. Standards &…