Regulatory, quality and clinical

MedTech RQC Ltd offers Regulatory affairs and Clinical consultancy for Medical device, pharma and cosmetics industries.

We have a combined experience of over 70 years experience within these industries. The types of services we offer as follows:

Quality

  • Supplier audits, internal audits
  • Quality Management Systems (ISO 9001, ISO 13485)
  • Root cause analysis and corrective and preventive actions
  • Training
  • Strategic planning
  • Sourcing suppliers

Clinical

  • Clinical documentation (Clinical Evaluation reports)
  • Clinical trial  management
  • Data management
  • Human Factors Engineering studies

Regulatory

  • Global regulatory submissions  and strategy (USA, EU, MENA, Asia/ASEAN, Canada, South America, Australia, Russia, etc)
  • Strategic planning
  • Updating documentation to EU MDR, IVDR regulations + gap analysis
  • Project Management
  • Support in every stage of product development to commercialisation
  • Technical guidance related to standards
  • Software as a medical device and AI
  • PRRC
  • UK based RP
  • Sourcing suppliers and vetting them
  • Compliance + generation of packaging and product labelling and documentation (instruction manual etc)
  • Regulatory approval of container closure systems for pharmaceutical/cosmetic products
  • Start-up company package – Regulatory foundation for every biotech start-up!!!
  • Human Factors Engineering studies
  • Biocompatibility
  • Military and humanitarian product approvals

Training

  • Training in regulatory standards for medical devices, pharma and cosmetics, Country specific regulations for approval and product development, Clinical trials,  Clinical trial documentation, Quality Management Systems, auditing
  • Introductory regulatory affairs
  • Step-by-step training on how to develop a product within a regulatory framework and save money and time!

Director

Dr Fizza D’monte Khan founded MedTech RQC Ltd has over 15 years of experience in the Biotech industry, working within healthcare and diagnostics, and currently runs her own consultancy.

You can find out more about Dr Fizza Khan on LinkedIn
A full CV is available on request:
If you would like to get in touch with Dr Khan you can reach her at: