ISO 13485 : 2016 - Quality Management for Medical Devices
ISO 13485:2016 is an internationally recognized standard for Quality Management Systems (QMS) specifically designed for the medical device industry. It helps organizations ensure the consistent design, development, production, installation, and delivery of safe and effective medical devices while meeting regulatory requirements.
At IndianSalahkar, we provide end-to-end ISO 13485:2016 Certification services across India. Our experts assist with documentation, implementation, audit preparation, and certification support to help medical device businesses achieve international quality standards and regulatory compliance.
Who Needs ISO 13485:2016 Certification?
- Medical Device Manufacturers
- Medical Equipment Suppliers
- Medical Device Distributors
- Healthcare Product Companies
- Diagnostic Equipment Manufacturers
- Surgical Instrument Manufacturers
- Medical Device Exporters
Time Required
ISO 13485:2016 Certification is generally completed within 7 to 30 working days, depending on the organization's size, documentation readiness, and certification requirements.
Why Choose IndianSalahkar?
- Experienced ISO certification professionals
- Complete documentation and implementation support
- Quick and hassle-free certification process
- Affordable and transparent pricing
- Pan-India service coverage
- Dedicated support until certification is obtained
Get your ISO 13485:2016 Quality Management System for Medical Devices Certification with IndianSalahkar and demonstrate your commitment to quality, safety, and regulatory compliance in the medical device industry.
ISO 13485 : 2016 - Quality Management for Medical Devices — plans & fees
All plans include expert support and no hidden cost.
Basic Plan
- No Hidden Cost
- Including Govt Fees
- Validity Period 3 Year
- ISO Certificate
- Not Applicable
- Not Applicable
- Not Applicable
Silver Plan
- No Hidden Cost
- Including Govt Fees
- Validity Period 3 Year
- ISO Certificate
- MSME Registration
- Not Applicable
- Not Applicable
Gold Plan
- No Hidden Cost
- Including Govt Fees
- Validity Period 3 Year
- ISO Certificate
- MSME Registration
- GST Registration
- Not Applicable
Platinum Plan
- No Hidden Cost
- Including Govt Fees
- Validity Period 3 Year
- ISO Certificate
- MSME Registration
- GST Registration
- Trademark Registration
Documents required
- PAN Card
- GST Certificate / MSME
- Minimum two Purchase bills
- Minimum two Sales Bills
- Declaration
- MOA, AOA and Incorporation Certificate (If Company)
- Other documents as required
How we get it done
- Choose a servicePick what you need or ask us to suggest the right structure.
- Share your detailsFill the enquiry form or message us on WhatsApp.
- Expert call-backOur executive calls you to confirm scope and fees.
- Send documentsShare the checklist documents online — no office visit needed.
- Get it doneWe file, follow up and deliver your certificate.
Watch: ISO 13485 : 2016 - Quality Management for Medical Devices explained
Frequently asked questions
What is ISO 13485 ?
It is designed to be used by organizations throughout the life cycle of a medical device, from initial conception to production and post-production, including final decommission and disposal. It also covers aspects such as storage, distribution, installation and servicing, and the provision of associated services. In addition, the standard can be used by other internal and external parties, such as certification bodies, to help them with their certification processes, or by supply chain organizations that are required by contract to conform. ISO 13485 helps an organization design a quality management system that establishes and maintains the effectiveness of its processes. It reflects a strong commitment to continual improvement and gives customers confidence in its ability to bring safe and effective products to market
What are the benefits for this ISO 13485 ?
• Demonstrate compliance with regulatory and legal requirements
• Ensure the establishment of QMS practices that consistently yield safe and effective medical devices
• Manage risk effectively
• Improve processes and efficiencies as necessary
• Gain a competitive advantage
What are the documents required ?
1. PAN Card
2. GST Certificate / MSME
3. Minimum two Purchase bills
4. Minimum two Sales Bills
5. Declaration
6. MOA, AOA and Incorporation Certificate (If Company)
7. Other documents as required
What is Medical Device ?
A medical device is an instrument, apparatus, implement, machine, implant, in vitro reagent, or other similar article, that is intended for use in the diagnosis, prevention and treatment of disease or other medical conditions. There is a huge variety of medical devices, ranging from basic hand tools to complex computer controlled machines. These include simple devices like wound dressings and scalpels ; durable devices like wheelchairs and dentist chairs ; implantable devices like cardiac pacemakers and monitors, prosthetic limbs and prosthetic joints ; life-supporting devices like respirators and lung ventilators ; sophisticated, software-controlled devices like CT scanners and MRI machines; and in vitro diagnostic reagents and test kits
Why was ISO 13485 Revised ?
All ISO standards are reviewed and revised regularly to make sure they remain relevant to the marketplace. ISO 13485:2016 responds to the latest QMS practices, reflecting the evolution in medical device technology and changes in regulatory requirements and expectations. This ensures that the standard remains compatible with other management system standards, including the new edition of ISO 9001.
Start your ISO 13485 : 2016 - Quality Management for Medical Devices today
Share your details and get a clear timeline and all-inclusive quote from our experts.
