Strategic Advisory & Due Diligence
Due diligence &
MedTech
regulatory strategy
Poor regulatory anticipation costs more than the advice. We step in before.
From bringing a device to market to pre-investment compliance audits, ISOFAC GROUP works with manufacturers, importers, distributors and subcontractors on decisions where compliance determines value creation.
In MedTech, regulatory choices are never neutral. A poorly scoped clinical indication delays CE marking by twelve months. A label modified by a distributor can reclassify them as a manufacturer under EU Regulation 2017/745. A quality system gap at a subcontractor travels up the liability chain. And in an acquisition, a fragile technical file can erase a target’s valuation.
Our role: identify these friction points before they become costs, and build regulatory decisions with you that serve your commercial trajectory.
A calibrated approach based on your regulatory status
Manufacturer, importer, distributor or subcontractor: your regulatory challenges are not the same. Neither are our recommendations.
Manufacturers — Market access strategy
The issue
For a device in development or an existing product to be extended, market access strategy is decided before the file is submitted. The scope of claimed clinical indications, the retained classification (Annex VIII MDR), the product configuration and the conformity assessment route determine both the time to CE marking and the total cost of compliance.
Our approach
Build an initial scope that is broad enough to address a viable market and targeted enough to accelerate access, then structure a post-marking extension roadmap based on clinical data accumulated through post-market surveillance.
Typical deliverables
- — Classification analysis and documented justification
- — Mapping of claimable clinical indications vs. available evidence
- — Progressive marking strategy (v1 → extensions)
- — Conformity assessment route selection and notified body pre-shortlisting
Importers — Securing regulatory status
The issue
Article 13 MDR strictly governs importer obligations. But the real risk lies elsewhere: Article 16 provides that an importer who modifies labelling, the intended purpose, or affixes their own brand without a contractually framed agreement becomes a manufacturer under the Regulation, with all associated obligations.
Our approach
Audit your labelling and packaging practices, secure contracts with non-EU manufacturers, and identify operations that shift your regulatory status. Where the commercial strategy genuinely requires a proprietary brand, structure the transition toward a manufacturer status that is assumed rather than imposed.
Typical deliverables
- — Labelling / packaging / IFU audit
- — Article 16 reclassification risk mapping
- — Review of non-EU manufacturer contracts (including REP mandate)
- — Compliance plan or manufacturer transition plan
Distributors — White label and own brand
The issue
The widespread practice of white label / private label is one of the points where the boundary between distributor and manufacturer is most fragile. Article 16 applies: depending on what is affixed, modified or declared, you remain a distributor, become jointly liable, or become the manufacturer in the eyes of the authorities.
Our approach
Precisely qualify your white label operations against Article 16, structure agreements with original manufacturers (OEM agreements), and manage the transition to manufacturer status when that is the most coherent commercial strategy.
Typical deliverables
- — Regulatory qualification of each private label line
- — Audit of OEM agreements and responsibility sharing
- — Securing plan or manufacturer transition plan
- — Distributor traceability, vigilance and FSCA procedures
Subcontractors & contract manufacturers
The issue
Contract manufacturers, production subcontractors, sterilisation or packaging service providers intervene at a critical point in the supply chain. Their quality system, contractual agreements and scope of intervention determine the solidity of their clients’ regulatory files.
Our approach
Structure an ISO 13485 quality management system calibrated to the scope actually assumed, formalise quality agreements with principal manufacturers, and clarify the boundary of responsibilities on sensitive topics: process validation, controls, batch release, shared CAPAs.
Typical deliverables
- — Implementation or overhaul of the subcontractor ISO 13485 QMS
- — Template quality agreements with principal manufacturers
- — Mapping of shared responsibilities
- — Preparation for client audits and notified body inspections
Assessing regulatory compliance before a financial transaction
Before an acquisition, equity stake or industrial partnership, the regulatory compliance of a MedTech target is one of the most determining factors, and one of the least well assessed by conventional approaches.
For financial funds & acquirers
We provide a regulatory and quality read of the target, translated into quantified risks and actionable conditions precedent.
For industrial buyers in external growth
We assess the regulatory integrability of the target, transfer risks (sites, notified bodies, technical files) and the cost of bringing it up to standard.
Our due diligence audit method
- 01 Document review (technical files, certificates, audit reports, CAPA plans)
- 02 On-site quality system audit (ISO 13485 and MDR requirements)
- 03 Product portfolio assessment (classification, MDR status, post-market surveillance)
- 04 Post-market vigilance and FSCA risk mapping
- 05 Summary report ranking findings (red flags / yellow flags / improvements) with estimated financial and timeline impact
Deliverables
- — Regulatory & quality due diligence report
- — Costed post-acquisition remediation plan
- — List of recommended conditions precedent and warranties
- — Executive summary for investment committee
A project to scope or a target to assess?
Whether it is a market launch, a review of your regulatory status or an external growth transaction, an initial conversation allows us to qualify the issue and calibrate a relevant intervention.