Navigate global regulatory pathways and achieve market authorisation. We classify, plan, prepare and defend submissions for medical devices and IVDs, then maintain every registration through change and renewal.
Classify the device, confirm the intended purpose and identify gaps in evidence and documentation.
Define the pathway for each market and the evidence each one requires, with timelines and owners.
Prepare, compile and submit dossiers, then manage review cycles and deficiency responses.
Assess changes, notify reviewers, renew registrations and keep the file current.
Market authorisation takes different legal forms: CE marking after conformity assessment in the EU, FDA clearance (510(k)), De Novo grant or PMA approval in the US, and national licences, certifications or registrations elsewhere. Our detailed pages keep these distinct.
For manufacturers using clinical data from one region to support approval in another.
We manage the manufacturer's side of the relationship. Conformity assessment and certification decisions remain with the Notified Body.
For Indian manufacturers moving to higher-risk devices and for overseas companies entering India.
Every finding is tied to a clause, rated by severity and paired with a remediation action and owner. The report becomes the work plan for remediation, not a document that sits on a shelf.
Illustrative extract · not from a client file
| Reference | Finding | Severity | Remediation |
|---|---|---|---|
| MDR Art. 32 | No SSCP for an implantable Class IIb device | Critical | Author SSCP, align with CER and IFU |
| Annex III · 1.1 | PMS plan lacks indicators and thresholds for trend reporting | Critical | Revise PMS plan with defined indicators |
| Annex II · 6.1 | Biological evaluation predates ISO 10993-1:2018 | Major | Gap analysis, chemical characterisation, updated BER |
| Annex I · 1, 8 | Benefit–risk conclusion not linked to clinical data | Major | Cross-reference RMR and CER conclusions |
| Annex I · 23 | Label symbols not referenced to ISO 15223-1 | Minor | Symbol justification and IFU glossary |
Portfolio-level programmes for legacy MDD, AIMDD and IVDD devices, with governance, prioritisation and Notified Body planning.
MDR & IVDR transition → United StatesGap assessment against the Quality Management System Regulation, remediation and inspection readiness.
QMSR readiness → Global marketsPathways, documentation, local representation and post-market duties for 13 priority markets.
Global regulatory consulting →Careful planning, clear decisions and well-built documentation decide how a Notified Body review goes. This is the sequence we follow on every CE marking engagement.
Reconfirm classification, select the conformity route and gather the regulatory intelligence that shapes the plan.
Review your existing assets, agree the documentation plan, owners and timeline.
Author the technical, clinical, risk and post-market documentation that is missing or out of date.
Independent SME and QC review of every document against the GSPR and the applicable guidance.
Assemble the technical documentation and the EU Declaration of Conformity. Appoint an Authorised Representative if you have no EU presence.
Final review of the submission package before it goes to the Notified Body.
Draft and review responses to technical and clinical questions, and manage resubmission.
Certificate issued, EUDAMED updated and the device handed over to post-market surveillance.
Share the device, its class and your target markets. A senior specialist will come back with the likely pathway, the evidence gaps we see and a practical plan.
