Medical Devices
Consultancy Service for ISO 13485 - Certification of Medical Devices
By Anuvartan Consultancy LLP
At Anuvartan Consultancy LLP, we specialize in providing expert consultancy services for medical device manufacturers seeking certification under ISO 13485 and the Indian Certification of Medical Devices (ICMED) scheme. These certifications are critical to ensuring product quality, regulatory compliance, and access to domestic and global markets.
Importance of ISO 13485 Certification
Ensures compliance with Indian and international regulatory requirements.
Boosts product credibility, safety, and effectiveness in the global market.
Facilitates access to new markets, including Europe (CE marking), Canada, and other regulated regions.
Enhances organizational efficiency and product quality through structured QMS.
Increases customer trust and helps win public and private tenders.
Certification Bodies for ISO 13485 in India
ISO 13485 certification can be obtained through reputed certification bodies such as:
TÜV SÜD
BSI Group India
Intertek India
UL India
DNV GL
SGS India
IRCLASS These bodies are accredited and recognized both in India and globally, depending on your market access goals.
🇮🇳 ICMED – India’s Indigenous Medical Device Certification
The Indian Certification of Medical Devices (ICMED) is an initiative by the Quality Council of India (QCI) and AiMeD to standardize and improve the quality of medical devices manufactured in India.
Levels of ICMED Certification:
ICMED 9000 – Based on ISO 9001 (general QMS)
ICMED 13485 – Based on ISO 13485 (device-specific QMS)
ICMED Plus – Includes product testing and certification for performance and safety
Benefits of ICMED Certification:
Enhances market reputation and brand trust
Supports Make in India and boosts local competitiveness
Simplifies regulatory clearances in India (e.g., CDSCO licensing)
Facilitates entry into government procurement systems
Adds value in international trade and export readiness
Medical Device Classification (as per CDSCO Guidelines)
Pricing for consultancy services depends on the risk class of your medical device:
Class A – Low risk (e.g., thermometers, surgical gloves)
Class B – Low-moderate risk (e.g., hypodermic needles, suction equipment)
Class C – Moderate-high risk (e.g., infusion pumps, bone fixation plates)
Class D – High risk (e.g., heart valves, implantable defibrillators)
Our Expertise
At Anuvartan Consultancy LLP, we have a dedicated team of trained experts with extensive experience in:
Gap Analysis and Documentation
QMS Implementation (as per ISO 13485:2016)
Internal Audits & Management Reviews
Coordination with Notified Certification Bodies
Post-certification Support & Surveillance Readiness
Pricing Structure
Our pricing is customized based on the class of your medical device, level of certification (ISO/ICMED), and scope of support required. Contact us for a personalized proposal based on your product category and certification goals.
We provide end-to-end guidance, from documentation to successful certification, tailored as per your device class and business goals.
