Gain confidence and peace of mind regarding the quality of your medical products with the assistance of our highly experienced quality assurance specialists.
Quality systems for medical device and drug manufacturers in Asia must be performing at the highest standards to eliminate product imperfections and malfunctioning, especially in low-cost Asian countries such as China, India, and Vietnam. In more advanced countries like Japan, quality management systems and requirements to register and market your products are extremely intricate and complex.
Pacific Bridge Medical is a leader in assisting medical businesses with quality assurance (QA), quality control (QC), and quality management systems (QMS) that enable them to successfully source, manufacture, and register their products in the Asian markets.
Ensuring the quality of your medical products may include essential measures such as:
- Performing on-site audits at your Asian facilities
We will send experienced local Asian auditors to the client’s factories or subcontract manufacturers in Asia to evaluate and monitor the production process. Our Asian offices employ inspectors with substantial FDA and international auditing experience, so it is not necessary to fly in experts from the U.S. or EU to conduct the quality audits. Our on-the-ground staff in Asia is fully capable of conducting business in multiple languages.
- Finding independent labs to test products for quality
- Training local personnel on Western quality standards
- Preparing the documentary requirements and determining any necessary corrective actions
- Conducting extensive due diligence and compliance auditing
Although local Asian manufacturers often claim adherence to international standards such as ISO 9001, ISO 13485, and CFR 820, they may not actually adhere to these standards in practice.
Contact us today to learn more about how we can assist your medical company with quality systems and compliance in Asia.
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