Area of expertise
Regulatory Affairs
Regulatory affairs keeps a product marketable across its entire lifecycle: conformity under MDR (EU 2017/745), IVDR (EU 2017/746) and pharmaceutical law, from the technical documentation and notified-body engagement through EUDAMED registration and labeling to vigilance and post-market surveillance. We run submissions and authority interactions so that market access never fails on formal gaps.
- Biotech
- IVD
- MedTech
- Pharma
All topics
25 topics in Regulatory Affairs
CE Marking →
CE marking for medical devices under EU 2017/745: classification under Annex VIII, choice of conformity assessment route, technical documentation under Annex II/III, notified body support and declaration of conformity, across all classes from I to III.
Change Management →
Building and reviewing GMP-compliant change control systems for pharma, biotech, medtech and IVD: risk assessment under ICH Q9(R1), regulatory impact assessment, variation classification under Regulation (EC) No 1234/2008 and change control for validated IT systems under GAMP 5.
Clinical Compliance →
Clinical compliance for sponsors: GCP gap analysis in line with ICH E6, clinical audits at investigator sites and CROs, TMF build-up and review based on the DIA TMF Reference Model, plus inspection readiness for inspections by the FDA, EMA and national authorities.
DiGA Approval →
DiGA approval consulting for the BfArM procedure: eligibility check under Sec. 33a SGB V, study design for the positive healthcare effect, data security preparation per BSI TR-03161 and an AbEM (application-accompanying outcome measurement) concept aligned with the 2026 DiGAV amendment, for both the fast-track and the regular procedure.
EU AI Act →
EU AI Act consulting for AI in medical devices, IVDs and GxP processes: high-risk classification under Art. 6, obligations under Art. 8 to 15, technical documentation under Annex IV, plus integration with MDR (EU 2017/745), IVDR (EU 2017/746) and the draft GMP Annex 22 on AI.
EUDAMED →
EUDAMED consulting for MedTech and IVD companies: actor registration (SRN), UDI data management, certificate linking, and migration of vigilance and PMS processes to the mandatory EUDAMED reporting channels under MDR Art. 33 and IVDR Art. 30.
FDA Clearance & Approval →
Guidance through US market access for medical devices: classification and pathway selection, predicate strategy and substantial equivalence under FD&C Act Sec. 513(i), pre-submission meetings (Q-Sub), 510(k) submission in the eSTAR template, as well as De Novo and PMA procedures, including US Agent and QMSR preparation.
Health Authority Interaction →
Preparation and support of health authority interactions for pharma, biotech, medtech & IVD: scientific advice and meetings with the EMA and FDA, applications and variations to national authorities such as BfArM and Swissmedic, as well as inspection and CAPA communication.
International Market Access →
International approval strategies for pharma, biotech, MedTech and IVD: prioritizing target markets, the FDA pathways 510(k), De Novo and PMA, registrations with PMDA, NMPA, ANVISA and GCC authorities, and third-country compliance for the UK (UKCA) and Switzerland (MepV).
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Other areas
Product Development & Regulatory Strategy
From classification and regulatory strategy through to development and study planning.
Market Access, RWE & Reimbursement
Market access, health economics, real-world evidence and pricing and reimbursement strategy.
Quality Management & Compliance
QM systems, audits, computer system validation and data integrity under ISO 13485, GMP and 21 CFR Part 11.
Supply Chain & Technical Operations
Supply chain, manufacturing, shortage management and technical operations optimization.
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