Regulatory

The Medilink Innovation and Commercialisation and Regulatory course was fantastic with relevant content bespoke to our request for training. The interactive content and innovation management tools will help us manage and optimise our portfolio. The learnings gained from this course have upskilled our entire team. Great course!

Medilink provided us with consultancy services which covered extending the intended purpose and product claims for one of our legacy devices. The work identified key user needs associated with using the device for a new clinical indication and has helped us articulate a series of new claims and has fed into our R&D projects in designing new predictive test methods, identifying the acceptability of the benefit risk ratio from competitor benchmarking and also input into our clinical evidence general plans. We look forward to working with Medilink in the future.

Medilink have authored a number of clinical evaluation reports for our family of class III implantable tissue regenerative products and we have been delighted in the speed and quality of the service and reports, which have also satisfied the notified body. We look forward to continuing our relationship with Medilink

Medilink has been instrumental in helping us navigate complex UK, EU, and US regulations, develop a compelling value proposition, and refine our product labelling and positioning strategy. The Medilink team also provided crucial guidance on planning and understanding the structure, as well as the primary and secondary endpoints, of future clinical trials—insights that will be invaluable for our resource allocation and strategic planning. Furthermore, they identified potential partners through thorough due diligence, assessing gaps in their portfolios and their preferred strategic approaches to growth. Medilink’s contribution has been invaluable in advancing our journey toward commercialization.

Let me first take this opportunity to thank you very much for your contributions over the past 2 years or so. Without this, our business unit would not be what it is today. The work you have completed sets a very high standard.

BioMin Technologies commissioned Medilink to author a Clinical Evaluation Report (CER) for a class IIB device technical file submission with a tight deadline and were delighted with both the quality and speed of the report. In fact, it’s the best overview and review of our product I have seen and we will use it for technical, marketing and other purposes. Many thanks to Medilink on a great job.

Medilink authored a development Clinical Evaluation Report and we were delighted with the quality of the work, it was comprehensive, insightful and also provided us with a much deeper understanding of alternative solutions and competitor products. We look forward to working with Medilink again in the future.