Regulatory support

The medical industry is highly regulated and the day-to-day implications and impact of regulations can take a while to understand and appreciate. With almost 40 years working solely in the medical sector, our specialists provide you with the medical device regulatory support you need to get your product through regulatory approval and onto the market.

The global regulatory landscape is highly complex. Combining a network of regulatory associates with our consultants’ experience, we can help you get your device approved by regulators in the most efficient way.

Keeping up to date with regulations

Regulations are constantly changing, so to ensure your device is compliant, a good understanding of current interpretation and future updates is vital. We are active members of several international committees and working groups, which keeps us up to date with any upcoming changes. These groups include:

ISO standards working groups and committee, including: ISO/TC84 devices for administration of medicinal products and catheters and working groups related to the updates to existing sections of 11608
The Organisation for Professionals in Regulatory Affairs (TOPRA)
International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC RS)

This knowledge and experience are used daily to support the development of MedTech, drug delivery, surgical and diagnostic devices and ensure global regulatory compliance.

Bespoke medical device regulatory support

We offer regulatory support throughout your medical device development, or alternatively a standalone service helping with:

Gap analysis of your Human Factors Engineering file.
Gap analysis of your device development documentation.
Support with developing your regulatory strategy to meet global requirements.

Get our Regulatory Handbook

Our Regulatory Handbook has tips, guidance and case studies, from people at Team and friends in the industry. Click here to get a free copy in the post.