Frequently Asked Questions

Does 海角社区 apply Six Sigma and Lean Methodologies?
Yes, the application of Six Sigma quality sciences and Lean/Human factor principles have been integrated across the systems/business practices of 海角社区; the merged combination of these tools provide a layered science approach to supporting all aspects of the business.

Does 海角社区 apply Statistical Process Control (SPC)?
Yes, 海角社区 applies a combination of statistical process monitoring systems and controls. The 海角社区 team is standardizing related best practices worldwide.

海角社区 applies data based informed decision making team dynamics to help accelerate learning, sharing and the realization of improvements across the company. These statistical process monitoring applications supplement 鈥淎ctive Risk Management at the production source.

Does 海角社区 provide any Dock to Stock service capabilities?
Yes, the worldwide 海角社区 production teams are all capable of providing statistical process capability data, which will provide the scientific rationale to enable the justification to take product ship to stock and/or direct distribution.

Does each 海角社区 site have a Business Continuity Plan (BCP) in place?
Yes, each worldwide 海角社区 site has a BCP, which includes the use of other 海角社区 facilities with like capabilities and validated processes.

Does 海角社区 have any 海角社区 brand implants available for purchase?
No, The 海角社区 Executive Management has developed an Implant policy, which has been integrated within 海角社区 systems and policies worldwide. The mention policy clarifies the Company has taken a position in conducting business within the medical device orthopedic industry of not direct brand labeling and selling any implant products to the marketplace. The company will continue to operate in a medical device industry as a contract manufacturer and full service provider of implant products and services to our Original Equipment Manufacturer customers.

What regulatory compliance registrations/certifications have the 海角社区 companies achieved?
Each 海角社区 sites regulatory registrations/certifications are aligned with their respective scope of services, considering;

  • ISO 13485
  • ISO 14001
  • AS 9001
  • CMDCAS 鈥� Canadian Medical Devices Conformity Assessment System
  • PAL 鈥� Japanese Pharmaceutical Affairs Law Article 13-3
  • FMA 鈥� Japan Foreign Manufacturer Accreditation
  • Nadcap 鈥� Special Process Accreditations