ISO 13485 Certification is the internationally recognized standard for Quality Management Systems (QMS) in the medical device industry. It focuses on ensuring the consistent design, development, production, installation, and servicing of medical devices that meet regulatory and customer requirements.
This certification helps medical device manufacturers establish a robust framework for risk management, traceability, and process control throughout the product lifecycle. By adopting ISO 13485, organizations demonstrate their ability to provide safe, reliable, and effective medical products that comply with international regulatory expectations.
ISO 13485 Certification enhances credibility in the healthcare industry, boosts global market access, and assures patients and customers of the organization’s commitment to quality and safety. It’s essential for companies aiming to supply medical devices in regulated markets such as the EU, US, or GCC.
