Certificates, Regulations and Standards

Meeting regulatory standards.

At Phillips-Medisize, we champion compliance standards, so our processes are characterized by simplicity, efficiency, and effectivity.

Whether it be for device development, contract manufacturing, lifecycle management or legal manufacturing, you can expect a partner for whom meeting regulatory requirements is a matter of course.


Certificates, regulations and standards we live by:

  • ISO 13485 Quality Management Systems for Medical Devices
  • ISO 14001 Environmental Management
  • FDA 21 CFR 820 Quality System Regulation Medical Device Good Manufacturing Practices
  • FDA 21 CFR 210/211 Good manufacturing practice in manufacturing, processing, packing or holding of drugs; general and Good manufacturing practice for finished pharmaceuticals
  • Medical Device Directive 93/42/EEC
  • Medical Devices Regulation (Regulation [EU] 2017/745)
  • Japan Quality Management System Compliance (MHLW Ordinance No. 169)
  • China CFDA YY/T 0287 Medical Devices — Quality Management Systems — Requirements for Regulatory Purpose
  • Canadian Medical Devices Regulations (SOR/98-282)
  • Regulated software and APP development
  • Lean and Six Sigma methodologies

Visit our global facilities to see which certificates, standards and regulations we live by at our different facilities.

Environment, Health and Safety

At Phillips-Medisize, we act with proper regard for the rights of others. Nothing is more important than human life and the safety of employees, contractors, community members and all those affected by our business. That is why we put safety first. We also drive environmental excellence and comply with all laws and regulations.