About ISO 13485:2016 – Medical Devices Quality Management System
ISO 13485 is the internationally accepted standard for companies involved in the design, production, installation, servicing, and distribution of medical devices. It ensures product safety, risk management, regulatory compliance, and consistent quality throughout the medical device lifecycle.
This certification is essential for manufacturers, suppliers, distributors, and service providers in the medical device industry.
Benefits of ISO 13485 Certification
Demonstrates compliance with global medical device regulations
Ensures quality, reliability & safety of devices
Reduces product risks and improves patient safety
Helps meet requirements for CE Marking, FDA, and other approvals
Mandatory for many export markets & hospital supply contracts
Improves process control & operational efficiency
Enhances customer trust and brand value
Supports tender eligibility in healthcare procurement
Process of Getting ISO 13485 Certified
Submit Application – Fill the ISO 13485 request form on Regenovate.
Document Review – Evaluation of quality processes & device handling controls.
Audit Process (Online/On-site)
Certificate Issued – Valid for 3 years.
Annual Surveillance Audits to maintain certification.
Documents Required
Company Registration (GST / MSME / Incorporation)
Medical device process flow / technical documentation
UDI/FDA/CE documents (if applicable)
Address Proof
Quality policy & manuals (if available)
Why Choose Regenovate
Fast and transparent certification processing
Experienced medical device auditors
Affordable pricing
PAN-India support
Globally accepted ISO certification
Dedicated compliance team for regulated industries
Who Should Apply
Medical device manufacturers
Distributors & traders
Sterilization units
Calibration & servicing companies
Hospitals & diagnostic equipment handlers
Dental, orthopedic, and surgical equipment makers
Disposable & consumable manufacturers
ISO 13485 is suitable for any organization involved in the medical device supply chain.
