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Start from your situation, not from our services.
Most regulatory problems arrive as a situation, not as a request for a service. These eight cover the large majority of enquiries; each names the trigger that usually prompts it, the first fixed-scope deliverable, and the page that explains the work.
Eight situations, eight first deliverables
Each card names the trigger that usually prompts the enquiry, the first fixed-scope deliverable, and where to read more.
- J1 Launching a first device A prototype exists, there is no regulatory pathway yet, and an investor is asking "what class is it?". First deliverableClassification and pathway memo, fixed scope, 10 working days Book a pathway call →
- J2 Entering the EU A notified body has quoted, or asked for MDR or IVDR technical documentation. First deliverableTechnical documentation gap report against Annex II/III and the GSPRs Request a technical documentation review →
- J3 Entering the US A 510(k), De Novo or PMA decision is due, and QMSR readiness is uncertain. First deliverablePathway and QMSR readiness assessment Discuss your FDA strategy →
- J4 Entering India An overseas manufacturer needs an import licence and a local authorised agent. First deliverableCDSCO licensing route map (form, authority, sequence, timeline) Explore your CDSCO pathway →
- J5 Audit or inspection ahead An ISO 13485 surveillance audit, MDSAP audit, FDA inspection or notified-body audit has a date. First deliverableMock-audit style QMS gap assessment with a closure plan Request a QMS gap assessment →
- J6 Biocompatibility or materials question A laboratory has proposed a full test battery, or a reviewer has asked for a toxicological risk assessment. First deliverableBiological evaluation plan with endpoint rationale, then the TRA Discuss your biological evaluation →
- J7 Software, AI or cybersecurity SaMD classification, AI change control, section 524B cybersecurity content or the EU AI Act is on the table. First deliverableIntegrated software, cybersecurity and AI regulatory plan Plan your SaMD submission →
- J8 IVD manufacturer A reviewer wants performance evaluation evidence beyond analytical data, or the IVDR class is unclear. First deliverableIVDR classification memo and performance evaluation plan outline Discuss your IVD regulatory strategy →
Five kinds of manufacturer
Behind the eight situations are five recurring profiles, and knowing which you are shortens the first call.
The device startup, two to twenty people, often engineer-founded, with a prototype and an investor asking which class the device is. The first deliverable is almost always the classification and pathway memo.
The established Indian manufacturer going abroad, CDSCO-licensed, with a distributor asking for CE marking or an FDA clearance. The work starts with a gap report against the target market's technical documentation requirements and usually becomes a QMS and technical-file project.
The overseas manufacturer entering India, from the EU, the US, Singapore or Japan, with an Indian distributor or a hospital tender and no import licence. The route map comes first, then the licensing project.
The RA or QA lead with one technical gap: a reviewer's deficiency letter on biocompatibility, a notified-body non-conformity on the risk file, a laboratory quote that seems too large. These are the fixed-scope assessments, and they often stay fixed-scope.
The IVD manufacturer, often laboratory-born, surprised by an IVDR classification or asked for performance evaluation evidence beyond analytical data. The classification memo and performance evaluation plan outline come first, with a named IVD collaborator; the dedicated page is in preparation.
Your situation is not on this list?
Describe it in a sentence. Most regulatory problems map onto one of these within the first five minutes of a call.