Certificates, Standards, and Regulations
Whether it be 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.