Punyam.com provides ISO 13485 Certification consultancy services, issuing certificates for medical device manufacturers for 3 years after successful pre-assessment and registration assessments. The certificate is valid until the date of issue and undergoes surveillance audits within 3 years. ISO 13485 is based on ISO 9001 but emphasizes meeting regulatory and customer requirements, risk management, and maintaining effective processes. The certification aligns an organization's management system with FDA's Quality System Regulation requirements and other global regulatory requirements. The standard can be implemented by industries to establish, implement, maintain, and improve quality management systems, ensure conformity with customer and regulatory requirements, demonstrate conformity with ISO 13485:2016, and ensure effective product traceability and recall systems. Punyam also offers an ISO 13485 documents and training resources like ISO 13485 documents kit, ISO 13485 auditor training ppt kit, ISO 13485 Lead auditor training, ISO 13485 auditor training, and ISO 13485 Lead implementer training.

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