Regulatory Excellence, engineered with care.
Regulatory documentation, traceable from requirement to evidence.
Medical device and IVD regulatory consulting for manufacturers entering the EU, US and India.
Biological evaluation and toxicological risk assessment, quality systems, technical documentation and market access.
Led by Tanish Kamdar, an engineer turned regulatory specialist, from Delhi.
Tanish Kamdar
Founder and Principal Consultant
- Graduate Certificate in Medical Device Regulatory Affairs, National University of Singapore
- B.Tech, Electronics and Communication Engineering
- Four years in semiconductor design verification before regulatory affairs
Where are you right now?
Start from the problem in front of you. Each entry names the first deliverable, its scope and the page that explains it.
- 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 →
Eight service pillars, one traceable file
Every pillar feeds the same technical file. Biological evaluation leads because it is where the practice is deepest; the others carry the file from strategy to post-market.
Flagship
06
Biological evaluation, toxicological risk assessment and E&L
A laboratory has proposed a full battery; a reviewer has asked for a toxicological risk assessment; a material changed and nobody knows what that means for the file. The answer in every case starts with endpoint selection under ISO 10993-1:2025 and ends with a document a toxicologist on the other side can follow line by line.
Biological evaluation plan and report (ISO 10993-1:2025)
Toxicological risk assessment (ISO 10993-17:2023)
Extractables and leachables study design (ISO 10993-18:2020+A1:2022)
Breathing-gas-pathway evaluation (ISO 18562-1 to -4:2024)
Discuss your biological evaluation →
- 01 Regulatory strategy and market access Classification, pathway, market sequencing, pre-submission strategy, representation
- 02 QMS and audits ISO 13485:2016, FDA QMSR, MDSAP readiness, internal audit, CAPA, supplier control
- 03 Electrical safety and EMC IEC 60601 applicability matrix, essential performance, test planning, report review
- 04 Risk management ISO 14971:2019 — plan, hazard analysis, dFMEA, pFMEA, use-related risk, benefit-risk, traceability
- 05 Technical documentation and design controls MDR/IVDR Annex II and III, GSPR checklist, medical device file, UDI and EUDAMED data, labelling, traceability
- 07 Software, SaMD and cybersecurity Qualification and classification, IEC 62304 documentation, usability, 524B cybersecurity, AI change control, EU AI Act
- 08 Post-market surveillance and vigilance PMS system and plan, PMS report and PSUR, PMCF and PMPF, vigilance, FSCA, trend reporting, CAPA
From the knowledge centre
All articles- Biological and clinical evaluation ISO 10993-1:2025: how endpoint selection changes under the sixth edition The sixth edition reframes biological evaluation as a risk-management activity rather than a test programme. That changes how endpoints are selected, how exposure is counted and what a plan has to say before any sample reaches a laboratory. This article works through the changes with the logic a reviewer will apply.
- Biological and clinical evaluation Toxicological risk assessment under ISO 10993-17:2023: a worked structure A toxicological risk assessment is where biological evaluations most often succeed quietly or fail loudly. This article sets out the structure of a TRA under the 2023 edition, step by step, with what a reviewer checks at each one and the shortcuts that produce deficiency letters.
Tell us where you are. We will tell you what comes first.
A 30-minute scoping call, complimentary, to understand your device, markets and constraints. A written scope follows within three working days.