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Home » products » Quality Assurance and Regulatory Affairs


Quality Assurance and Regulatory Affairs

You will benefit from substantial experience and the professional background of our consultants, trainers and auditors when re-structuring SOP’s, training staff on the latest regulations, or auditing study sites, internal departments or suppliers.

MSOURCE offers:

  • Expertise in European clinical study regulations for pharmaceuticals, biologics, vaccines and medical
    device product development
  • Performance of the following types of audit: Quality support (co-monitoring); Clinical study on-site; Clinical study in-house; System and qualification audit
  • Review study documentation
  • SOP writing, review and training
  • Regulatory and ethics committee submissions with input from experts on local requirements
  • Assurance on quality and regulatory compliance of your clinical development programme