SUPERIOR QUALITY MANAGEMENT

Leaner processes to stay ahead

Technologies advance. There’s no stopping them. We keep pace, but that’s not where we hold the edge. Our core strength lies elsewhere. It’s in our zero tolerance for quality compromise.

So how do we achieve it? It’s quite simple:

  • Support customer requirements for timeline and cost effective products
  • Validate our processes in the markets they operate in

Part of this strategy is to ensure total compliance to regulatory guidelines. We achieve this by leveraging our extensive industrial knowledge on various procedures – from product registration and CE marking, maintenance of the Device History Record (DHR) and technical file, biocompatibility testing and validation and support sterilization, to updates on regulations and communication of new/revised regulations and intellectual property protection.

In addition, all our facilities are accredited to leading medical and quality management systems. 

Click here to full the view list.

All Forefront Medical facilities are registered to ISO 9001:2008 and ISO: 13485:2003. All facilities are also compliant to MDD 93/42/EC which is the Medical Devices Directive for European Community, MHLW Japan’s Pharmaceutical Affairs Law (PAL) and Ministerial Ordinance #169, ISO 15378 which is focused on primary packaging materials for medicinal products, ISO 14001 which is focused on environmental management, ISO 18001, which is focused on occupational health and safety management, and ISO 27001, focused on information security management.

 

All facilities are FDA CFR 21 Part 820 and Japan registered as foreign contract manufacturers. Our Jiangsu, China facility currently holds a FDA Establishment Registration and Class 2 Product Registered (510k), as well as China FDA (CFDA).

Learn more about ways we can help your team increase market competitiveness.

Powered by Hello Pomelo