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ISO 13485 Certification Services in India – Accredium Certifications
ISO 13485 Certification – Ensuring Quality in Medical Devices
Accredium Certifications & Assessment Services, a trusted name in the industry with extensive expertise, offers ISO 13485:2016 Certification Services across India. Our proficiency helps medical device manufacturers, suppliers, and service providers meet international quality standards with unwavering confidence
Achieve global recognition for your medical devices by aligning with ISO 13485, the international standard that ensures regulatory compliance, product safety, and customer satisfaction.
No matter where you are in India, our team will support you through every step, from gap analysis to certification. Start reducing compliance risk today. Imagine the potential setbacks associated with delaying your ISO 13485 certification, from compliance issues to customer dissatisfaction. With our comprehensive support nationwide, you can ensure safety, compliance, and market competitiveness.
We offer comprehensive support for ISO 13485 quality management systems, certification consulting, and implementation guidance across India.
Our ISO 13485 certification services are available throughout India, reaching both major cities and regional centers.
We assist you in understanding the costs of ISO 13485 certification in India and guide you in choosing the right certification body.
1. Initial Consultation: We learn about your business, products, and compliance needs.
2. Gap Analysis: We identify any gaps in your current quality system.
3. Documentation Support: We help you prepare policies, procedures, SOPs, and records for ISO 13485.
4. Implementation Assistance: We provide staff training, conduct internal audits, and help you get ready for compliance.
5. Pre-Audit Review: We check your readiness before the certification audit. Certification Audit – Conducted by accredited ISO 13485 auditors
7. Ongoing Surveillance Audits: We help you maintain your certification through regular audits.
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Industries We Serve
ISO 13485 for Medical Device Manufacturers
ISO 13485 for Surgical Instruments Producers
ISO 13485 for Dental Equipment Manufacturers
ISO 13485 for Orthopaedic Implants & Prosthetics
ISO 13485 for Diagnostic Equipment Suppliers
ISO 13485 for Healthcare Product Distributors
ISO 13485 Sterilisation and packaging units
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We serve clients in the following locations:
We provide ISO 13485 certification service. We offer ISO 13485 certification services in and throughout India, covering all major cities and regions.
What is ISO 13485
ISO 13485 is a globally recognised standard for Quality Management Systems (QMS) for medical devices, ensuring compliance with regulatory requirements, product safety, and customer satisfaction.
Whether you are in Delhi, Mumbai, Bengaluru, Hyderabad, Kolkata, Chennai, Pune, Ahmedabad, Surat, Jaipur, Lucknow, Chandigarh, Bhopal, Indore or any other city, our experts guide you from gap analysis to certification.
ISO 13485 Certification India
* ISO 13485:2016 QMS for Medical Devices
* ISO 13485 Certification Consultants in India
* Medical Device Quality Certification India
ISO 13485 Certification Services Delhi, Mumbai, Bengaluru, Hyderabad, Kolkata, Chennai, Pune, Ahmedabad, Surat, Jaipur, Lucknow, Bhopal, Indore, Patna, Ranchi, Guwahati, Chandigarh, Coimbatore, Kochi, Nagpur, Vadodara
* ISO 13485 Certification Cost in India
* Best ISO 13485 Certification Body in India
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## **Our ISO 13485 Certification Process**
1. **Initial Consultation** – Understanding your business, products, and compliance needs
2. **Gap Analysis** – Identifying gaps in your existing quality system
3. **Documentation Support** – Policies, procedures, SOPs, and records for ISO 13485
4. **Implementation Assistance** – Staff training, internal audits, and compliance readiness
5. **Pre-Audit Review** – Checking readiness before the actual certification audit
6. **Certification Audit** – Conducted by accredited ISO 13485 auditors
7. **Ongoing Surveillance Audits** – To maintain your certification
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## **Industries We Serve**
* **Medical Device Manufacturers**
* **Surgical Instruments Producers**
* **Dental Equipment Manufacturers**
* **Orthopedic Implants & Prosthetics**
* **Diagnostic Equipment Suppliers**
* **Healthcare Product Distributors**
Sterilization & Packaging Units
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We service the following Locations
We provide ISO 13485 Certification Services in:
Delhi, Noida, Gurugram, Faridabad, Ghaziabad, Chandigarh, Ludhiana, Amritsar, Jaipur, Jodhpur, Udaipur, Mumbai, Pune, Nagpur, Nashik, Aurangabad, Ahmedabad, Surat, Vadodara, Rajkot, Bengaluru, Mysuru, Mangaluru, Hyderabad, Visakhapatnam, Vijayawada, Chennai, Coimbatore, Madurai, Kochi, Thiruvananthapuram, Bhopal, Indore, Raipur, Ranchi, Patna, Guwahati, Shillong, Imphal, Aizawl, Agartala, Kohima, Itanagar, Port Blair, Leh, Srinagar, Shimla, Dehradun, Lucknow, Kanpur, Varanasi, Gorakhpur, Prayagraj, Meerut.**
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Frequently Asked Questions (FAQ) – ISO 13485 Certification India
Q1: What is ISO 13485 certification?
A: ISO 13485 is an international standard for a quality management system specific to the medical devices industry. It ensures safety, quality, and regulatory compliance.
Q2: Who needs ISO 13485 certification in India?
A: Medical device manufacturers, suppliers, distributors, and related service providers.
Q3: How long does it take to get ISO 13485 certified?
A: Typically, 2–6 months, depending on your organization’s readiness.
Q4: Is ISO 13485 mandatory in India?
A: For specific categories of medical devices, it is required to comply with regulatory frameworks like CDSCO. For exports, it’s often mandatory.
Q5: What is the cost of ISO 13485 certification in India?
A: Cost varies depending on company size, number of locations, and scope of accreditation.
Q6: Can you help with ISO 13485 documentation and training?**
A: Yes, we provide complete documentation kits, templates, and on-site/off-site training.
Q7: Is your certification valid internationally?
A: Always ask for IAF-accredited certificates. We work with IAF and NABCB-accredited ISO 13485 certification bodies recognised globally.
Q8: Do you offer services in small towns or only in metro cities?
A: We offer services across India, including small towns and industrial clusters.
Q9: Can I get ISO 13485 certification online?
A: Implementation can be done remotely for documentation and training, but the audit is generally on-site.
Q10: How do I start my ISO 13485 certification process?
A: Contact us via phone or email, and our consultants will guide you step-by-step.
Call to Action
Get your ISO 13485 certification in India today with Accredium Certifications.
📞 Call/WhatsApp: +91-9716231789
Why Choose Accredium Certification
Get to Know Us
Accredium provides PAN India Service of ISO 13485 Certifications and audits from Delhi to Kanyakumari, Gujarat to Arunachal Pradesh
Why ISO 13485 Certification is Important for Your Business
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Compliance with International Standards for medical devices
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Increased Market Access – essential for exports to Europe, USA, and other global markets
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Enhanced Product Safety & Quality
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Improved Operational Efficiency
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Better Customer Confidence & Trust
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Regulatory Compliance with Indian CDSCO, CE Marking, US FDA requirements
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