High Edge Consulting Ltd


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.

Visit our website www.highedge.co.uk to find more details on the services we can provide to you.

  • UK/EU Regulatory Compliance
  • Worldwide Compliance
  • Sterilisation
  • Microbiology & Contamination control
  • Interim Support
  • Quality Management System
  • Process Validation
  • Medical device auditing services
  • Auditing Regulatory and Quality Compliance
  • Open Public training courses
  • In House training courses
  • EC Rep 
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