Medical Device Documentation Support

Pharmi Med Ltd is a one stop solution for medical devices which covers guidance for European requirements for CE marking using Medical Device Directive 93/42 EEC, In Vitro Medial Device Directive 98/79 EC, FDA requirements for United States, as well as ROW (Rest of World). Our concept to market graphic explains the stages where we will help you. Our support includes knowledge of the appropriate standards and several product speci c standards.

Our Medical Device support services cover Class I, II and III

Pharmi Med can help from set up, to assistance with new product development, to ongoing validation and regulatory, and remediation work from audits. We can also help you with a Gap Analysis.

Pharmaceutical Documentation Support

Pharmi Med Ltd has supported many pharmaceutical companies, including start-up businesses, to meet cGMP (current good manufacturing practises), Eudralex Annex 15 and MHRA requirements, including FDA part 210 and 211. We also use the latest PIC/S (Pharmaceutical Inspection Cooperation Scheme) guidelines and GAMP (Good Automated Manufacturing Practice) methods.

Our pharmaceutical documentation support includes many of the services listed in the services section, including (but not limited to) –

  • SOP Write Up
  • Setting up Quality Management Systems or
  • Review of Quality Documentation
  • Validation
  • Laboratory Setup
  • Cleanroom Setup
  • Facility Setup/New or Modified Production Lines

We can support combination devices which include the requirements of both medical devices and pharmaceutical regulations, as well as herbal/supplementary products which may require GMP.

Pharmi Med Ltd will achieve GMP requirements of “establishing documented evidence that establishes a high degree of certainty that a particular process will consistently produce a product that provides the previously established specifications and quality attributues are available.”

Complete our form below and we will contact you to discuss your specific requirements: