Applying a regulatory approach: A guide for medical device startups

Written by Andrew Goodenough, Quality Assurance and Regulatory Affairs Manager

When you’re a start-up in the early stages of product development, navigating the regulatory landscape can seem pretty daunting.

Are you aware of the mandatory regulations and safety standards necessary to support the development and manufacture of your medical device?

Are you confident of the best approach and interactions necessary to effectively and compliantly manage your device from concept through to commercialisation?

Are you aware of the industry best practices and guidance that can help you seamlessly navigate the design and development process to guarantee a compliant, safe, and effective medical device?

Why not step into a real-life situation to test your knowledge?

Meet Claudia, she is off to meet with a regulatory affairs consultant to discuss her new device - but does she have everything in order? Let’s find out.

Regulatory and Product Development Consultancy

At ITL, we can support you through every stage of product development. Our consultancy service allows you to tap into the knowledge of our experienced team who can guide you through the complex regulatory landscape of medical and IVD devices. Discover how we can assist with global product regulatory activities to help secure the future of your device.

Contact us

We are an ISO 9001, ISO 13485:2016 and FDA GMP certified full-service contract design and manufacturing partner with an exclusive focus on medical, diagnostic and analytical instruments. No matter where your device is in its life-cycle, we’d love to hear from you. Get in touch with a member of our team to discuss your project and how we could help you. Please call us +44 (0)1233 638383, email us or simply start a conversation with our team on LiveChat.

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