Case Studies
At Apotech, we have worked with a
huge range of clients all around the world.
With consultants and teams present in 30 key life science markets, we have successfully executed projects in over 110 countries and helped a large number of innovative medical devices and products enter the market with complete regulatory compliance.
Keep reading to discover some of our most recent case studies.
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…
Borderline device classification
Borderline device Classification Introduction Classification of borderline product (cosmetics VS medical device) Our client, a multinational cosmetics and wellness product manufacturer identified revenue opportunities marketing their cosmetics devices with increase claims. Apotech was engaged to perform a blanket regulatory assessment of cosmetic devices and provide judgement and pathways for market authorisation as a medical device…
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