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Regulatory Affairs
Navigating the complicated world of MedTech regulations can be tricky. But it’s also vital to ensure successful market entry and compliance. Each of our services is designed with this in mind, helping you deliver seamless regulatory submissions and outcomes.
Unlock regulatory success in life sciences
Prioritise patient safety and compliance in global markets
At Apotech, we recognise the importance of regulatory affairs within life sciences. That’s why our strategic approach is grounded in expertise, providing you with all the tools you need to not only ensure regulatory compliance but also prioritise patient safety.
By integrating regulatory considerations early on in the development phase, we can guide you through complex approval processes, guaranteeing that your products meet rigorous quality and safety benchmarks.
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Trusted by top-tier teams worldwide
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Tailor-made regulatory solutions built around you
At Apotech, we offer a comprehensive range of auditing services to suit your exact needs. From remote audits to MDSAP audits, we can also tailor our approach depending on your requirements, helping support you along each step of the way.
At Apotech, we maintain the highest standards to protect and uphold the regulations required to develop medical products. Thanks to our structure, we can respond to changing conditions and customer requirements, offering tailored regulatory solutions that you can rely on.
- We provide comprehensive project support: With the know-how to support a wide variety of projects, we offer a full spectrum of activities to support you throughout the entire medical device development cycle.
- We have a global reach: With headquarters in London and Paris, our offering extends worldwide. We also specialise in supporting non-EU businesses, leveraging our network of industry experts around the world to navigate international regulatory landscapes.
- We provide comprehensive project support: With the know-how to support a wide variety of projects, we offer a full spectrum of activities to support you throughout the entire medical device development cycle.
- We have a global reach: With headquarters in London and Paris, our offering extends worldwide. We also specialise in supporting non-EU businesses, leveraging our network of industry experts around the world to navigate international regulatory landscapes.
Why choose Apotech for MedTech regulatory affairs?
With former regulatory agency expertise to our name, our role extends beyond market entry.
From global submissions to post-market support, we offer a comprehensive range of services designed to help you establish trust, maintain your reputation and deliver compliant life sciences operations successfully.
FDA
ongoing projects with FDA (Breakthrough, PMA, 510(k), Qsub)
EU MDR
Support to transition to
clients
UKCA MARKING
Five ongoing submissions
FAQs on MedTech regulatory affairs
Whether it be the difference between UKCA and CE Marking, or a notified body versus an approved body, we understand that the world of MedTech regulatory affairs can be hard to understand at times. That’s why we aim to make the complex simple.
Here are some of the questions we get asked most often.
Featured case studies
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…
PathwayGen’s 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 Full testimonial available upon…