Understand the remediation work needed before or after closing.
Technical and Commercial Due Diligence
ISO 13485 QMS and Technical Documentation Assessment for Medical Device Manufacturers
On-site, PAN India: checking whether the quality system and technical files behind a product will support its market access.
For a medical device business, much of its commercial value sits in its regulatory approvals. Those approvals rest on documentation: the quality system, technical files and records that prove each product is safe and performs as intended. An ISO 13485 certificate or a CE mark on file does not, on its own, confirm that this foundation is complete and current.
Suchigo Consulting provides an independent ISO 13485 QMS assessment and technical dossier review for acquirers, investors and manufacturers from India and overseas. We check whether documentation reflects actual shop-floor practice and meets current EU MDR and Indian Medical Device Rules (CDSCO) requirements.
What We Assess
A practical review of your quality system and product files
We assess whether the documentation is complete, current and consistent with how the facility actually operates.
| Area | What we review | What it tells you |
|---|---|---|
| ISO 13485:2016 QMS | Quality manual, SOPs, document and record control, change control, CAPA closure and effectiveness, complaints, internal audits and management review | Whether the QMS is implemented and effective, not just certified |
| CE marking technical dossiers | Technical documentation, General Safety and Performance Requirements (GSPR) checklist, Clinical Evaluation Report, labelling and post-market surveillance | Whether the technical file supports the CE mark and the transition to EU MDR |
| Risk management | ISO 14971 risk management files, design and process FMEAs, and whether they are updated with production and complaint data | Whether product and process risks are understood and controlled |
| Records and traceability | Device history and batch records, Device and Plant Master Files, electronic record controls and data integrity practices | Whether every product can be traced and records would withstand an audit |
Value for Investors and Owners
Know what comes with the approvals
When a buyer acquires a medical device company, it takes on the approvals and the obligations that come with them. Gaps in a technical file or weak QMS records can delay renewals, trigger notified body findings or restrict sales.
Identify approvals and certificates that need attention at a change of ownership, alongside your legal advisers.
Plan the documentation upgrades needed to move from a State FDA / CDSCO licence to EU MDR.
How the Assessment Works
From document review to a prioritised plan
We agree the scope with you, verify how the system works in practice and report findings directly to management.
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01
Scope and document collection
We agree the products and markets in scope and collect the QMS and technical documentation.
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02
Desk review
Our senior experts review procedures, records and dossiers against ISO 13485 and applicable regulatory requirements.
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03
Site verification
We visit the facility, PAN India, to verify that documented procedures are followed on the shop floor.
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04
Report and recommendations
Your management receives a gap analysis report with risk ratings and a prioritised action plan to upgrade the QMS and dossiers. After the report, Suchigo can advise on implementing upgrades for the complete system or selected areas, working alongside your team as catalyst and advisor.
Why Suchigo Consulting
Senior experience. Independent perspective.
Led by Mr. Sunil Gokhale, with over 43 years of CEO-level experience, our senior experts have built quality systems for medical device facilities and supported CE, US FDA and other international regulatory audits, with a wide network of industry specialists to draw on.
We read documentation the way an auditor does, then check it against what happens in the plant. We work alongside your team as catalyst and advisor. All assessments are carried out under strict confidentiality.
Frequently Asked Questions
QMS and documentation assessment, explained
What is an ISO 13485 QMS assessment?
It is an independent review of a medical device manufacturer’s quality management system against ISO 13485 requirements. Suchigo Consulting checks both the documentation and how it is implemented in the facility.
Does Suchigo Consulting review CE marking technical dossiers?
Yes. Suchigo Consulting reviews CE marking technical documentation, including the GSPR checklist, risk management, clinical evaluation, labelling and post-market surveillance files.
Is a valid ISO 13485 certificate enough during due diligence?
No. A certificate shows the system passed an audit at a point in time. A due diligence assessment checks whether the system is still complete, current and effective.
Can this assessment help with an EU MDR upgrade?
Yes. It identifies the gaps in QMS and technical documentation that need to be closed before a manufacturer moves from a State FDA / CDSCO licence to EU MDR compliance.
Can the QMS assessment be combined with other due diligence services?
Yes. It can be combined with our technology, quality and regulatory, HR, operational and commercial due diligence services for a complete technical and commercial due diligence of the facility.
PAN India Pharma and Medical Device Projects
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Share your requirement, and we’ll help you understand what stands behind the certificates and dossiers.
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