Medical devices consulting
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Regulatory and Technical Assistance for Class I, II, and III Medical Devices

Pharmaceutical Development Services Limited delivers comprehensive medical device supportand regulatory compliance services. PDS can also help ensure QA compliance including operating procedure advice and writing, as needed.

Medical Devices

Through our strategic alliance with High Edge Consulting Limited, PDS delivers the following medical device services:

  • CE marking (all classes), 510(k), CMDCAS and other worldwide regulatory compliance
  • Specific projects such as technical file authoring, sterilisation validation, internal auditing
  • Covering skills gap
  • Filling knowledge gap
  • Supporting growth into new markets
  • Supporting growth with new product lines
  • Specialist fields (microbiology, sterilisation, clinical evaluations and biological reviews)
  • Interim cover (maternity, sickness, urgent need)
  • Resolution of Auditor findings
  • Gobal coverage - including USA, Canada, Australia, Europe and others
  • Candidate screening for regulaotry and quality positions
  • Medical devices training

Non-EU Device Manufacturers

For Device Manufacturers based outside the European Union, PDS can act as Authorised Representative. In this role, we maintain a watching brief on all matters of concern to the client, including regulatory updates.

Vigilance

PDS will liaise with Competent Authorities in respect of Vigilance matters. We advise, assist, and submit Adverse Incident Reports as required to the relevant Competent Authorities on behalf of our clients.

About High Edge Consulting Limited

High Edge Consulting works closely with PDS to help companies in the medical device sector operate within the relevant regulatory framework and comply with the quality systems demanded by their products. We deliver practical advice and solid solutions to get the job done. Established in 2002 and certified by BSI to ISO 9001 and ISO 14001, High Edge Consulting work with a range of medical device clients, from small start-ups to global corporate companies across all device classifications, sterile and non sterile.