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Get ISO 13485 certification for your medical device manufacturing unit with complete regulatory support, documentation, internal audits, quality compliance setup, and certification approval. PSR Compliance ensures faster processing, accuracy, and full adherence to ISO 13485:2016 standards for medical safety and device quality.
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ISO 13485 Certification is the core global compliance requirement for medical device manufacturers, importers, exporters, sterilization service providers, distributors, and component suppliers who want to legally operate and enter international markets. Under ISO 13485:2016, companies must follow strict quality controls, device traceability, risk assessments, and safety validations before products reach hospitals, laboratories, clinics, or end users.
Achieving ISO 13485 is not just a certification milestone — it is proof that your organization follows a controlled QMS that prevents device failure, contamination risks, malfunction, and patient harm. From CE marking approval to MDR compliance and US-FDA alignments, ISO 13485 certified companies hold a stronger market reputation and wider export acceptance. With professional regulatory support from PSR Compliance, you receive structured documentation, gap audit planning, regulatory mapping, internal audit readiness, and coordination support until final certification issuance.
ISO 13485 is an international standard designed specifically for medical device manufacturers, traders, importers & distributors to ensure safety, precision, traceability, risk control, and regulatory compliance throughout the medical device lifecycle.
It proves that your organisation follows Quality Management System (QMS) practices compliant with ISO 13485:2016 guidelines and meets global medical device requirements such as:
This certification applies to all medical device-based organisations including:
ISO 13485 gives medical device businesses complete credibility in both Indian and global healthcare markets. It improves device safety, strengthens documentation, and ensures risk-free manufacturing.
Documentation determines certification speed. If records are incomplete, audit failures increase.
Here’s how PSR Compliance handles your entire ISO 13485 process:
Assessment of existing QMS vs ISO 13485 requirements.
Includes:
Training of your internal team on:
A complete audit before the certification body arrives.
External audit by accredited ISO body.
Validity: 3 YearsSurveillance audits: Year 1 & 2
We provide complete ISO 13485:2016 documentation in PDF including:
High
Moderate
Medium
3–7 Days
7–15 Days
15–25 Days
30–45 Days
We ensure zero audit failure with:
• 100% compliance documentation• NABL & CE-aligned medical device consulting• Complete ISO 13485 medical device file preparation• CDSCO + MDR + CE integration support• Dedicated compliance expert panel• On-site & remote audit assistance• Expertise in sterile & implantable device category
📞 Direct Support: Delhi, Noida, Gurugram, Faridabad, Ghaziabad & PAN India
It is a medical device QMS standard ensuring safety and regulatory compliance.
Yes, for all medical device approval and export clearances.
3 years.
Yes, it is a core requirement.
Accredited ISO certification bodies.
Yes, during procurement.
Absolutely, it is globally recognized.
Every 3 years after surveillance checks
Yes, documentation and audits can be coordinated remotely.
Full documentation + audit + certification support.