MEDICAL DEVICES CONSULTING
Having the appropriate Quality Management System for medical device manufacturers in Asia must perform at the highest standards to eliminate product imperfections and malfunctions, especially in low-cost Asian countries like China, India and Vietnam. In more advanced countries like Japan, Quality Management Systems and requirements to register and market your products are extremely complicated.
Global Regulatory Partners (GRP) Quality Team has the skills and required quality certifications to assist medical device companies install and maintain their quality management systems (QMS). GRP’s quality controls and quality assurance will allow companies to keep their products registered and sold in markets throughout Asia.
GRP QA team has the experience and ability to perform the following types of quality audits:
GAP Analysis Audits
Audits performed to assess the level of compliance of a medical device company to one or more of the following quality standards: FDA 21CFR 820, ISO 13485, Japan PAL, PICs standards and Canadian Standards CMDR. The gap analysis is typically conducted before the implementation of a new quality system or before heath authority or notified body audit.
ISO 13485 Audit
Audits performed at medical device companies several weeks prior their ISO 13485 certification by their notified body. As an outcome, GRP QA team makes sure that companies are aware of all their non-compliances so they can address them prior to the occurrence of the official ISO 13485 certification audits.
Foreign Manufacturer Accreditation Audit (FMA)
Audits performed to help medical device companies prepare for the Japanese accreditation audit that need to be completed by PMDA (Japanese Health Authorities) before medical device registration in Japan.
Full or Partial Internal Audits
Audits performed at medical device companies to provide an independent review of their full or partial quality system. These audits can also be focused on areas where internal audits cannot be conducted by in-house auditor due to possible conflict of interest.
Contact us today to learn more about how we can assist your medical device company with quality control, quality assurance and quality management systems and compliance.