Blog

Start here — 70 guides

The MDR structure, actors, and core concepts every founder must understand before touching Annex I.

• What MDR 2017/745 actually regulates
• Notified Bodies, competent authorities, MDCG
• Classification rules and conformity routes
• Transition periods and 2023/607 amendment

Annex VIII Rules 1-22 — 46 guides

How to classify your device correctly the first time — and why getting it wrong costs months.

• Class I, IIa, IIb, III decision logic
• Rule 11 for software (SaMD)
• Classification justification document
• Borderline and qualification calls

Article 61 and Annex XIV — 51 guides

Clinical evidence that survives a Notified Body review, without burning your runway on unnecessary studies.

• Clinical Evaluation Report (CER)
• Equivalence and its three-dimensional proof
• When you need a clinical investigation
• PMCF planning and reporting

Articles 83-92 — 41 guides

Post-market surveillance and vigilance without turning it into paperwork theater.

• PMS plan and Annex III content
• Serious incident reporting timelines
• PSUR for Class IIa/IIb/III
• FSCA decisions and trend reporting

Annex II and labeling — 43 guides

Technical documentation that an auditor can navigate in minutes, not days.

• Annex II structure and GSPR mapping
• Device description and intended purpose
• Labeling and IFU requirements
• Cross-reference matrices

Identification and registration — 30 guides

Everything you need to know about EUDAMED, UDI, and what the Member States still want on top.

• UDI-DI vs UDI-PI and Basic UDI-DI
• EUDAMED modules and status
• National registration (DMIDS, ANSM, BASG)
• Multi-market UDI strategy

ISO 13485 + MDR Article 10(9) — 57 guides

A lean quality management system that passes audits without drowning the team.

• Minimum viable QMS for startups
• Design controls and design history
• CAPA without bureaucracy
• Supplier qualification

EN ISO 14971 + Annex I — 1 guides

Risk management that drives real design decisions, not a document produced for its own sake.

• ISO 14971 risk management file
• Hazards, hazardous situations, harm
• Risk controls and residual risk
• Benefit-risk and Annex Z trap

IEC 62304 + Rule 11 — 55 guides

Software as a Medical Device from first commit through post-market, without pretending you're not agile.

• Software safety classification (A/B/C)
• Requirements, architecture, verification
• SOUP and open source handling
• Significant change under Article 120

AI Act and Rule 11 — 40 guides

How MDR's static framework fits adaptive algorithms, and where the AI Act adds obligations.

• AI Act and MDR dual classification
• Training data and dataset hygiene
• Drift, explainability, transparency
• PCCP-style change control

EN 60601-1 and friends — 36 guides

Electrical safety, EMC, and systems engineering for medical hardware — from PCB to test lab.

• EN 60601-1 general requirements
• EN 60601-1-2 EMC
• Particular standards (60601-2-xx)
• Home, emergency, closed-loop devices

FDA + IMDRF + MDSAP — 45 guides

Market access beyond Europe, starting with the US and the major IMDRF jurisdictions.

• FDA 510(k), De Novo, PMA
• QMSR and ISO 13485 alignment
• MDSAP and one-audit strategy
• Country playbooks

PMF and strategy — 49 guides

Product-market fit, business models, and startup strategy for regulated MedTech — not a SaaS playbook.

• MedTech PMF reality check
• Beachhead markets
• Hospital procurement
• Case studies and pivots

Capital and reimbursement — 41 guides

How MedTech founders raise money, control burn, and plan for reimbursement from the first pitch.

• Angels, VC, strategic investors
• Non-dilutive funding (EIC, BMBF)
• Reimbursement by country
• HTA and value-based pricing

Team and operations — 37 guides

Building the team, supply chain, and operations layer that MDR actually requires.

• PRRC and RA hiring
• CMO and supplier management
• Scaling production under MDR
• Acquisition readiness