ISO 13485

ISO 13485 certification is independent proof that your company runs a quality management system that meets ISO 13485:2016, the international standard for medical devices. An accredited certification body audits your design (if in scope), production, purchasing, traceability, complaint handling and risk management, and issues a certificate valid for three years.

The Medical Devices Rules, 2017 require every licensed manufacturer to follow the quality management system in their Fifth Schedule, which closely follows ISO 13485. The ISO 13485 certificate itself is voluntary, but it is the most widely accepted way to show your system meets that level, and most OEM buyers and export markets ask for it.

Most Greendot ISO 13485 projects take 3 to 4 months from the gap assessment to the certification audit. The time depends on whether design is in scope, the number of device families, sterile or clean room processes, the state of your current system and how quickly your team can give time.

The cost has two parts: the consultant fee and the certification body fee, which you pay directly to the body. Both depend on your number of employees and sites, device classes, whether design and development is in scope, special processes such as sterilisation or clean rooms, and how much of the system already exists. After the free Gap Check we give you a written estimate for your plant.

The certificate is issued by an accredited certification body after a Stage 1 and Stage 2 audit. ISO itself does not issue certificates, and neither does a consultant. Greendot has no tie-up with any certification body, so you are free to choose any accredited body.

ISO 9001 is a general quality standard focused on customer satisfaction and continual improvement. ISO 13485 is written for medical devices and focuses on product safety and regulatory requirements: risk management across the product life, process validation, contamination control, traceability, complaint handling and a medical device file for each product. If you already have ISO 9001, we upgrade your system rather than starting again.

Yes. If you only manufacture to a customer's design, the design and development clause (7.3) can be excluded where the applicable regulations allow it. The exclusion is justified in your quality manual, and every other requirement still applies.

Yes. ISO confirmed ISO 13485:2016 after its 2025 systematic review and has not started a new edition. The US FDA has also incorporated ISO 13485:2016 into its Quality Management System Regulation since 2 February 2026, so the 2016 version remains the global reference.

In most cases it is not a legal requirement for suppliers, but medical device makers increasingly ask their critical suppliers, such as plastic moulders and sterile packaging makers, for ISO 13485 certification. Being certified helps you win and keep medical device customers.

Yes. Greendot supports medical device companies with CE marking for export to Europe under the EU Medical Device Regulation, including technical documentation, risk management and the ISO 13485 quality system that the Notified Body audits.

Our work is the quality management system that licensing inspections and Notified Body audits check. We build it, train your team and make it audit-ready. The licence application itself is filed by you or your regulatory partner.

Our consultants work on site across Gujarat and Maharashtra, including Ahmedabad, Vadodara, Bharuch, Ankleshwar, Surat, Valsad, Vapi, Daman, Silvassa, Umbergaon, Palghar, Boisar, Vasai, Mumbai, Nashik and Pune, from our offices in Valsad, Surat and Vadodara.