Welcome to High Edge Consulting, a medical devices consultancy that ensures medical device manufacturers comply with the relevant national and international Standards and European Directives
If you need help with Regulatory compliance and submissions, Quality Management Systems, Auditing, or need an EC Representative then call us now on 0115 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 that can work with them to maximise their effectiveness.
Based in BioCity Nottingham, we have consultants across the UK covering Europe, North America, and worldwide wherever quality medical devices are manufactured.
Call us now on 0115 921 6200 to discuss how we can help you achieve Regulatory and Quality Compliance.
Their friendly, practical advice ensured we complied with the regulatory and quality systems in a way that enhanced the manufacturing process without disengaging our workforce. Well done!
Andrew Debbage - Quality Manager, Lombard Medical Technologies
