Yes, ISO 13485 is basically mandatory for manufacturers of medical devices and in vitro diagnostic devices in the European Union (EU). While it’s not explicitly mandated by EU regulations, compliance with ISO 13485 is harmonized with the requirements of the Medical Device Regulation (MDR) and In-vitro Diagnostic Regulation (IVDR). Achieving compliance with this standard enables […]
Yes, ISO 13485 is primarily intended for organizations in the medical device industry (including suppliers) to ensure the safety and efficacy of medical devices throughout their lifecycle.
Manufacturers of medical devices or in vitro diagnostics are required to be ISO 13485 certified. Some, however, choose to also obtain ISO 9001 certification. Other organizations may opt solely for ISO 9001.
ISO 13485 is a standalone standard, separate from ISO 9001. But ISO 9001 is a subset of ISO 13485. So if you comply with ISO 13485, you also comply with ISO 9001.
ISO 13485 emphasizes regulatory compliance, risk management, and product safety in the medical device industry. On the other hand, ISO 9001 applies to various industries, focusing on general quality management principles and customer satisfaction.
The cost of hiring a consultant to implement a quality management system according to ISO 13485 can vary considerably due to several factors. These factors include whether you are a supplier to a manufacturer or a manufacturer of medical devices yourself, the existence and maturity of your current quality management system, the size of your […]
ISO 13485 certification is primarily required for manufacturers of medical devices. While a quality management system (QMS) in accordance with ISO 13485 is mandatory for manufacturers of medical devices, suppliers can benefit from an ISO 13485 certificate. They can access the market of medical device manufacturers more easily.
Yes, our post-certification support is designed to ensure that your QMS evolves with industry standards and regulatory changes.
Absolutely. Our services are scalable and relevant for everything from start-ups to multinational corporations.
The schedule varies depending on your current QMS status, but we strive for efficiency without compromising on quality.