If you make medical devices, components, sterile packaging or provide sterilisation and testing services, one question decides your next order: “Are you ISO 13485 certified?” In India, the Medical Device Rules, 2017 require a quality management system for manufacturing licences, and export buyers in Europe and the US expect ISO 13485 as standard.
Greendot Management Solutions helps medical device manufacturers implement ISO 13485 in a practical way — risk management, design control, process validation, traceability and CAPA — so you get certified, clear CDSCO inspections and win export customers.
• Applying for or renewing a CDSCO manufacturing licence?
• Has an export buyer asked for ISO 13485 or CE marking support?
• Are risk files, validation and traceability records incomplete?
India’s most experienced ISO consulting team since 1999 · 200+ companies ISO certified · 1,200+ mid and large-size companies served
Greendot Management Solutions is an ISO 13485 consultant in India, trusted by 1,200+ mid and large-size companies since 1999.
We help medical device manufacturers, component suppliers, sterile packaging makers and contract manufacturers implement ISO 13485:2016 — including ISO 14971 risk management, design and development control, process validation, traceability, internal audit and CAPA — and prepare for certification by an accredited certification body.
Our work supports CDSCO licensing under India’s Medical Device Rules, 2017, EU MDR technical documentation and the US FDA Quality Management System Regulation (QMSR).
Offices in Valsad, Surat and Vadodara, serving clients across India.
• Who we are: Greendot Management Solutions — ISO consultants since 1999
• Experience: 1,200+ mid and large-size companies served · 200+ companies ISO certified
• What we deliver: Gap assessment, ISO 13485 QMS, ISO 14971 risk file, Device Master File, validation, internal audit, certification support
• Regulations supported: CDSCO (Medical Device Rules 2017), EU MDR, US FDA QMSR
• Who it’s for: Device makers, component suppliers, sterile packaging, contract manufacturers, sterilisation and testing labs
• Where we work: Offices in Valsad, Surat and Vadodara — on-site across India
ISO 13485:2016 is the international quality management system standard for medical devices. It covers how devices are designed, produced, stored, installed and serviced so they are consistently safe and effective — with strong focus on risk management, process validation, traceability and regulatory compliance.
It is the basis for quality system requirements in many countries: India’s Medical Device Rules, 2017, the EU Medical Device Regulation (MDR), and the US FDA Quality Management System Regulation (QMSR), which incorporates ISO 13485 by reference and applies from February 2026.
India — CDSCO: Under the Medical Device Rules, 2017, every medical device manufacturer in India — Class A, B, C and D — needs a manufacturing licence, and the quality management system requirements in the Rules are based on ISO 13485. A working ISO 13485 system makes licensing and CDSCO or State Licensing Authority inspections far smoother.
European Union — MDR: CE marking under the EU MDR needs a quality management system, and ISO 13485 is the standard notified bodies expect.
United States — FDA QMSR: The FDA’s Quality Management System Regulation now incorporates ISO 13485:2016, so an ISO 13485 system is the foundation for supplying the US market.
Any company that designs, makes, packs, sterilises or tests medical devices — or supplies parts to those who do.
Diagnostic devices, monitors, surgical instruments and consumables
Hospital beds, patient monitors, infusion pumps and imaging equipment
Moulded parts, machined parts, electronics, tubing and connectors
Pouches, blister packs, trays and sterile barrier systems
Third-party and OEM manufacturing for Indian and global brands
EtO, gamma and steam sterilisation, testing and calibration labs
Software as a medical device and device-connected applications
Bone screws, plates, joint implants and dental implants
Syringes, catheters, gloves, masks, dressings and IV sets
Essential for: medical OEM suppliers, CDSCO licence holders and exporters to the EU, US and other regulated markets.
Different industries are already feeling the impact: We build a quality system that works on your shop floor every day — not just a set of documents to pass the audit.
Baseline study against ISO 13485, your device class and CDSCO, EU MDR or FDA needs.
Risk management file, FMEA and risk controls built into product and process.
Quality manual, SOPs, Device Master File, technical file and traceability records.
Process validation, sterilisation and cleanroom controls, calibration and monitoring.
Design inputs, verification, validation and design history records where applicable.
Team training, internal audit, management review and closure of every gap.
Hand-holding through Stage 1 and Stage 2 audits by an accredited certification body and closure of findings.
In 30 minutes we’ll review your device class, documents and plant, show you the gaps, and give you a clear plan, timeline and quote.
Transparent pricing. No hidden costs. Audit-ready certification guaranteed.
With offices in Valsad (head office), Surat and Vadodara, Greendot works on-site with medical device manufacturers in Ahmedabad, Changodar, Sanand, Vadodara, Rajkot, Vapi, Daman, Mumbai, Pune and the rest of India.
Building a complete management system? Combine ISO 13485 with ISO 9001, ISO 14001 and ISO 45001, or explore all our ISO certification consulting services.
Q1. What is ISO 13485?
ISO 13485:2016 is the international quality management system standard for medical devices. It sets requirements for designing, producing, storing and servicing devices so they are consistently safe and effective, with a strong focus on risk management, validation and traceability.
Q2. Is ISO 13485 mandatory in India?
Under India’s Medical Device Rules, 2017, all medical device manufacturers need a licence, and the quality management system requirements in the Rules are based on ISO 13485. ISO 13485 certification itself is voluntary, but it makes licensing and inspections much easier, and most export buyers require it.
Q3. What is the difference between ISO 9001 and ISO 13485?
ISO 9001 is a general quality standard for any industry. ISO 13485 is written for medical devices and adds requirements for risk management, design control, process validation, sterile products, traceability and regulatory reporting. It focuses on safety and compliance rather than customer satisfaction and continual improvement.
Q4. How long does ISO 13485 certification take?
Most companies are ready for the certification audit in 4 to 8 months, depending on device class, whether design and development is included, and the current state of documentation and validation.
Q5. What does ISO 13485 certification cost in India?
The cost depends on company size, device class, number of products and sites, and whether design control and sterilisation are in scope. The certification body’s audit fee is paid separately. Greendot shares a clear quote after a free ISO 13485 Gap Check.
Q6. Does ISO 13485 help with US FDA and EU MDR?
Yes. The US FDA’s Quality Management System Regulation incorporates ISO 13485:2016 by reference, and EU notified bodies expect an ISO 13485 quality system for CE marking under the MDR.
Q7. Do you provide ISO 13485 consulting in Gujarat and Maharashtra?
Yes. Greendot works from offices in Valsad, Surat and Vadodara, serving medical device manufacturers in Ahmedabad, Changodar, Vadodara, Rajkot, Vapi, Daman, Mumbai, Pune and across India.
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