ISO 13485 Audit Services in India – Medical Auditors
Medical QMS and ISO 13485 Audits in India
Pro QC International works with medical device manufacturers, importers and suppliers across India to evaluate and strengthen their QMS based on ISO 13485:2016. The audits we conduct are not generic checklists. They’re designed for businesses that need practical insight into their systems—where gaps exist, how procedures are functioning, and what changes can make the system more robust over time.
Our audits are conducted by experienced ISO 13485 auditors who understand medical production environments, supplier risks, and the compliance expectations tied to global distribution. Every audit is adjusted to reflect the client’s operational setup, product classification, and market access strategy.
Pro QC approaches ISO 13485 audits in India as more than a regulatory formality. These assessments are structured to give companies a practical understanding of how their quality systems function day to day. Instead of simply confirming that procedures exist, the focus is on how those procedures are applied, where gaps may be forming, and which areas present opportunities to strengthen control or reduce risk over time.
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Strengthen your QMS and elevate compliance with targeted ISO 13485 audits designed to enhance every layer of your medical device operations
Our ISO 13485 Audit Services in India
Pro QC doesn’t apply a one-size-fits-all model to ISO 13485 audits. Each assessment is tailored to reflect the organization’s priorities, the complexity of the product, and the development level of the supplier’s quality system.
- ISO 13485 QMS Audits – These are complete assessments of an organization’s ISO 13485 quality system.
- Supplier Audits and Evaluations – Pro QC auditors go on-site to evaluate whether suppliers meet ISO 13485 expectations and support the client’s own quality requirements.
- Internal ISO 13485 Audits – Independent audits conducted as part of internal system maintenance.
- Pre-Certification Support – Gap assessments carried out in advance of a certification or re-certification process.
- Training and System Implementation – Some companies need support earlier in the process, during system setup or when adapting to the ISO 13485 framework.
- CAPA Audits – These focus specifically on the Corrective and Preventive Action process.
These services are available in cities where medical manufacturing is concentrated across India. All audits are planned to fit client timelines and production schedules.
Our Team of Consultants and ISO 13485 Auditors in India
The auditors assigned to ISO 13485 audits in India include professionals with technical and regulatory backgrounds. Most have worked inside medical device companies or certification bodies. Their knowledge goes beyond what’s written in the standard—they know how quality systems operate day to day.
Pro QC selects auditors who understand the regulatory frameworks, including U.S. FDA regulations (21 CFR Part 820), MDSAP, and European MDR. Auditors are certified in ISO 13485 and regularly involved in audits that touch on multiple overlapping requirements.
Pro QC maintains auditor teams in key industrial cities across India, including Chennai, Pune, Bengaluru, Ahmedabad, and Hyderabad.
Identify risks early, tighten control, and secure device safety with ISO 13485 audit insights tailored to India’s medical manufacturing landscape
Working with an ISO 13485 Consulting Company in India
Many businesses looking to grow their presence in global healthcare markets choose to work with a third-party consultant to test their QMS under real-world conditions. An internal review can miss issues that become problems during a regulatory audit. A structured, objective audit helps prevent that.
Pro QC provides ISO 13485 audit reports that are clear and practical. Instead of generic statements, the reports include the overall compliance level, clause-by-clause results, collected evidence, and recommended corrective actions.
Audits often play a broader role than simply preparing for certification. They’re used during supplier onboarding, when introducing process changes, or as part of routine oversight in highly regulated environments.
Other Medical Device Audits Offered
Alongside ISO 13485 audits in India, Pro QC also carries out evaluations based on other standards relevant to medical manufacturing, such as:
- ISO 14644 – Cleanroom audits.
- ISO 11135 / ISO 11137 – Audits for sterilization procedures.
- FDA 21 CFR Part 820 – Audits conducted according to the U.S. FDA’s Quality System Regulation.
- MDSAP – Medical Device Single Audit Program.
For companies managing multiple certification or compliance goals, combined audits are offered. These may include:
- ISO 13485 + Cleanroom Control
- ISO 13485 + Sterilization Processes
- ISO 13485 + EU MDR Readiness
This combined approach saves time and ensures the business has a clear view of its overall compliance status.
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Founded in 1984, with over 40 years of experience, Pro QC is a trustworthy and dependable quality partner
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