What is ISO 13485:2016?
ISO 13485:2016 is the internationally recognized standard for Quality Management Systems (QMS) specific to the medical device industry. It outlines the requirements for organizations involved in the design, production, installation, and servicing of medical devices, as well as related services.
The standard ensures that medical devices consistently meet customer and applicable regulatory requirements, emphasizing risk management, process control, and product safety throughout the product lifecycle. Applicable to organizations of all sizes, it is a key requirement in many global medical device regulations.
Why Choose ISO 13485 Certification?
Demonstrates compliance with international medical device quality requirements
Increases market access in regulated regions and countries
Enhances customer trust through consistent product safety and quality
Strengthens risk management and regulatory compliance processes
Improves operational efficiency and traceability across the supply chain
Supports integration with other management systems such as ISO 9001
Facilitates smoother regulatory audits and inspections
Enhances post-market surveillance and continual improvement practices
Which Industries Benefit from ISO 13485?
ISO 13485 is applicable to a wide range of organizations in the medical device supply chain and related service sectors, including but not limited to:
Medical device manufacturers – companies producing finished medical devices for diagnostic, therapeutic, or monitoring purposes
Suppliers and component manufacturers – organizations providing parts, materials, or subassemblies used in medical devices
Sterilization and packaging service providers – businesses ensuring product sterility and safe distribution packaging
Medical software developers – companies designing and maintaining software for medical use, including embedded systems and standalone applications
Distributors and importers of medical devices – organizations responsible for bringing medical devices to market and ensuring regulatory compliance
Calibration and testing laboratories – facilities performing measurements, testing, and verification for medical device quality and safety
Maintenance and repair service providers – companies offering post-sale servicing to ensure continued device compliance and safety
Contract manufacturing organizations (CMOs) – third-party manufacturers producing devices on behalf of other companies
Healthcare institutions producing in-house devices – hospitals or clinics manufacturing custom devices for patient-specific needs
Why Work with BBS?
25 Years Experience
Trusted Certification Body
Auditors with Technical Expertise
Clear and Respectful Communication
Reliable and Transparent Processes
Efficient Process Management
Certification Process
Our certification process is designed in accordance with ISO/IEC 17021 to ensure impartiality, independency, and transparency. Each step is carried out by qualified personnel, auditors and decision-makers to evaluate the effectiveness and conformity of your management system.