- Regulatory Strategy
- Label Claims
- Category Determination
- Pre-submission meetings
- Selection of NB / AB
We are a small and dynamic medical device consultancy, meaning we can offer a more tailored and dedicated approach.
Our medical device regulatory consultants have a wealth of experience in a wide range of device technologies.
The medical device development consultancy services that we provide are based on expert technical knowledge.
We have a wealth of IVD consultancy experience in the development and regulatory conformity of IVDs.
We provide a full range of regulatory and development services for a wide variety of medical technologies including:
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"Andrew has the great combination of expertise with the ability to communicate this in simple language without losing any of the key points that need to be considered. He is very approachable and pragmatic, but with the right attention to detail. We at VBM would not hesitate in recommending Insight Regulatory for similar projects and look forward to continuing our work together in the future."
Peter Vernon – Partner, VBM Associates
"I cannot overemphasise the importance and value Andrew and the Insight team have provided to our company. Ocupeye has collaborated with key persons covering diverse disciplines to bring our medical device to market. Regulatory as part of the business jigsaw is complex and requires a thoroughly professional/reliable approach. We additionally needed pro-active leadership and ..."
Gordon Bott – CEO, Ocupeye Ltd
"We've had the pleasure of working with Andrew and the Insight team for several years, and their knowledgeable and pragmatic consultancy has been invaluable in the areas of biological safety, cleaning and sterilisation and more broadly supporting the upgrade of technical documentation. Their expertise has been critical in assisting with FDA and Notified Body responses, as well as our ..."
Technical Director, Orthopaedic Manufacturer
"I have had the pleasure of working with Andrew and the team at Insight Regulatory for many years. They have consistently supported us by conducting our internal and supplier audits, ensuring our processes and procedures remain up-to-date and compliant with the latest regulatory requirements. Additionally, we have relied on their expertise for consultation and support in developing ..."
Laura McBrown, Managing Director – G&B Electronic Designs Ltd
We offer a full range of regulatory services from the initial regulatory strategy right through to approval and the post market phase. Our insight into the regulatory requirements will pave the way for a smoother route to market.
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Whether you are looking for assistance with internal audits and CAPAs or to delegate the running of your entire quality management system, we can provide the most appropriate solution to help.
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From retrospective design documentation for legacy devices to planning the development strategy for your new product, our knowledge of the regulatory requirements for medical device product development will ensure the most efficient use of time and resources.
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