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. 

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All Forefront Medical facilities are certified to latest ISO 13485:2016 version. 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.


All manufacturing facilities are registered under US FDA and Japan as Foreign Medical Device Manufacturer. Our China Jiangsu facilities currently holds a NMPA establishment registration for Class III Product registered (510K), as well as China National Medical Product Administrator (NMPA).

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

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