Quality & Regulatory
Putnam Medical takes quality management very seriously. How could we not? When you’re in the business of manufacturing minimally invasive, life-saving devices, it’s important that your quality management systems are top notch. Putnam Medical closely follows all FDA Quality System Regulations, which includes our ISO Class 7 certified clean rooms.
Putnam Medical's Registrations:
- FDA Registered and inspected as a Contract Manufacturer
- ISO 13585:2016 Medical Devices Quality Management Certified
- 4,500 sq. ft. ISO Class 7 Certified Cleanroom
- 1,200 sq. ft. Class 7 R&D Cleanroom
