High Edge Consulting

If you need help with Regulatory compliance and submissions, Quality Management Systems, Auditing, or need an EC Representative then call us now on +44(0)115 921 6200.

We are experts in providing Regulatory and Quality compliance solutions to the medical device industry.

Whether you are new to Medical Devices or an experienced manufacturer, our experts can help you.

From completing a Technical File, drafting the 510 (k) submission , determining the optimum Sterilisation methodology to Auditing to the latest Medical Device regulations. We can help you and your company achieve your goals.

If your team requires training, we have experts on hand th...