Navigating the MDR as an early-stage startup seemed impossible. The team gave us a practical, audit-ready plan for compliance. We achieved our CE mark on schedule.
MedTech Regulatory Consulting
Your Partner for EU and USA MedTech Compliance
Mastering the EU MDR & IVDR Landscape
We provide clarity on the complex requirements of the EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746). We help determine device classification, interpret GSPRs, and identify the optimal conformity assessment route.
Device Classification Strategy
Accurate interpretation of classification rules (Annex VIII)
What This Means For You
Get your device classification right from the start. Proper classification determines your entire regulatory pathway, timeline, and costs. Misclassification can delay market entry by 6-12 months and cost hundreds of thousands in unnecessary testing.
Deliverable Outcome
- Classification analysis with rule-by-rule justification
- Comparable device (predicate) assessment
- Classification strategy document for Notified Body
- Risk-based classification optimization
Navigating GSPRs
Ensuring your device meets General Safety & Performance Requirements
What This Means For You
Build compliance into your product DNA. A systematic approach to GSPRs ensures you address all safety and performance requirements upfront, reducing the risk of costly redesigns and Notified Body findings.
Deliverable Outcome
- GSPR checklist with gap analysis
- Standards mapping to applicable GSPRs
- Evidence requirements matrix
- Compliance strategy documentation
Conformity Assessment Route Selection
Identifying the most efficient path based on device class
What This Means For You
Choose the fastest, most cost-effective route to market. The right conformity assessment strategy can reduce certification time by 3-6 months while maintaining full compliance.
Deliverable Outcome
- Annex IX-XII route comparison matrix
- Notified Body selection criteria
- Assessment timeline and milestone planning
- Cost-benefit analysis of assessment options
Understanding Economic Operator Roles
Clarifying obligations for Manufacturers, ARs, Importers
What This Means For You
Know exactly who is responsible for what. Clear definition of economic operator roles prevents compliance gaps, reduces liability exposure, and ensures smooth supply chain operations across EU member states.
Deliverable Outcome
- Economic operator responsibility matrix
- Authorized Representative selection guidance
- Importer/Distributor compliance requirements
- EUDAMED registration strategy
Navigating US FDA (Title 21 CFR) Regulations
We provide expert guidance through FDA regulations for medical devices, covering device classification, premarket pathways (510(k), PMA, De Novo), and Quality System Regulation (21 CFR Part 820) compliance.
Device Classification & Pathways
Determining FDA class and optimal submission route
What This Means For You
Select the right FDA pathway the first time. Correct classification and pathway selection can save 3-6 months in review time and prevent costly submission rejections or requests for additional information.
Deliverable Outcome
- FDA classification analysis (Class I, II, III)
- Predicate device identification and comparison
- 510(k), De Novo, or PMA pathway recommendation
- Submission strategy and timeline
Quality System Regulation (QSR)
21 CFR Part 820 compliance and implementation
What This Means For You
Build a QMS that withstands FDA inspection. Robust QSR compliance reduces warning letter risk and creates operational efficiency through clear processes and documentation controls.
Deliverable Outcome
- QSR gap assessment against 21 CFR Part 820
- Quality manual and procedure documentation
- Design controls implementation framework
- CAPA and risk management integration
Premarket Submissions & Notifications
510(k), PMA, IDE, and De Novo preparation
What This Means For You
Submit with confidence. Well-prepared submissions reduce FDA review cycles and get your device to market faster. Our structured approach ensures completeness and regulatory rigor.
Deliverable Outcome
- 510(k) or PMA submission package preparation
- Substantial equivalence documentation
- Clinical evidence strategy and compilation
- eSTAR submission formatting support
Establishment Registration & Device Listing
FDA compliance for commercial operations
What This Means For You
Ensure your business is legally authorized to market devices in the US. Proper registration and listing prevents import delays, compliance violations, and enforcement actions.
Deliverable Outcome
- Establishment registration guidance
- Device listing preparation and submission
- US Agent appointment support
- Annual registration maintenance plan
Global QMS: Ready for EU MDR/IVDR and FDA QSMR
We specialize in developing, implementing, and upgrading Quality Management Systems designed for seamless compliance with both European (EU MDR/IVDR, aligned with ISO 13485:2016) and American (FDA QSMR - Title 21 CFR Part 820) markets.
Unified QMS Strategy
Single system for dual-market compliance
What This Means For You
One QMS that satisfies both EU and FDA requirements. Eliminate redundant processes, reduce audit burden, and create operational efficiency while maintaining full regulatory compliance in both markets.
Deliverable Outcome
- Harmonized QMS architecture design
- Process mapping for dual compliance
- Documentation structure optimization
- Regulatory requirement crosswalk matrix
ISO 13485 & FDA QSMR Harmonization
Bridging EU and US quality requirements
What This Means For You
Leverage the FDA's shift toward ISO 13485 alignment through QMSR. Position your QMS for future regulatory harmonization while meeting current requirements in both jurisdictions.
Deliverable Outcome
- ISO 13485 vs QSR gap analysis
- Harmonized procedure templates
- QMSR transition readiness assessment
- Integrated audit program design
Comprehensive Risk Management (ISO 14971)
Integrated risk throughout product lifecycle
What This Means For You
Embed risk management into every phase of your product lifecycle. ISO 14971 compliance demonstrates safety commitment to regulators and reduces liability exposure while supporting regulatory submissions.
Deliverable Outcome
- Risk management file structure
- Risk analysis methodology selection
- Risk control measure implementation
- Post-market risk monitoring process
Dual-Market Audit Readiness
Preparation for Notified Body and FDA inspections
What This Means For You
Face audits with confidence. Systematic preparation reduces findings, prevents certification delays, and demonstrates your commitment to quality and regulatory excellence.
Deliverable Outcome
- Mock audit program and execution
- Audit response procedure templates
- Evidence package preparation
- Inspector interaction training
US FDA Documentation Expertise
We provide specialized support in preparing and managing comprehensive documentation essential for FDA compliance. Our services ensure your Design History File (DHF), Device Master Records (DMR/DHR), labeling, and Computer System Validation (CSV) packages meet rigorous FDA requirements.
DHF Compilation
Design History File preparation per 21 CFR 820.30
What This Means For You
Demonstrate design control compliance with a complete, audit-ready DHF. Proper documentation of your design history proves your device was developed according to established procedures and reduces FDA inspection findings.
Deliverable Outcome
- DHF structure and organization framework
- Design planning documentation
- Design inputs/outputs traceability matrix
- Design review, verification, and validation records
DMR & DHR Management
Device Master and History Records per 21 CFR 820.181/184
What This Means For You
Maintain complete manufacturing traceability. DMR and DHR compliance ensures every device is produced consistently and can be traced back to its manufacturing batch, critical for recalls and quality investigations.
Deliverable Outcome
- DMR structure and content definition
- DHR documentation procedures
- Production record templates
- Batch record traceability system
FDA Labeling & UDI Compliance
21 CFR Part 801 and UDI system requirements
What This Means For You
Avoid import holds and compliance violations due to labeling issues. Proper FDA labeling and UDI implementation ensures your devices can be distributed in the US and traced throughout their lifecycle.
Deliverable Outcome
- IFU and labeling content review
- UDI assignment and GUDID submission
- Label design and compliance verification
- Symbols and e-labeling strategy
Computer System Validation (CSV)
21 CFR Part 11 and data integrity compliance
What This Means For You
Validate your critical computer systems to prevent data integrity findings. CSV compliance ensures your software, spreadsheets, and automated systems produce reliable, auditable records that withstand FDA scrutiny.
Deliverable Outcome
- Validation master plan
- IQ/OQ/PQ protocols and reports
- Risk-based validation approach
- Data integrity assessment
Technical Documentation for EU Market Access
We guide you through structuring and compiling the extensive technical documentation required by MDR/IVDR Annexes II and III. We ensure completeness, compliance, and Notified Body review readiness, including planning, V&V, risk management, clinical evaluation, and labeling.
TD Structure Guidance
Annex II and III compliance framework
What This Means For You
Present your technical documentation in a format that facilitates Notified Body review. Proper structure and organization reduces review time, minimizes questions, and demonstrates your professionalism to auditors.
Deliverable Outcome
- Technical documentation index and structure
- Annex II/III checklist mapping
- Document control and version management
- Electronic submission preparation
CER/PER Support
Clinical and Performance Evaluation documentation
What This Means For You
Demonstrate safety and performance with robust clinical evidence. A well-structured CER/PER satisfies Notified Body expectations, supports conformity assessment, and provides the foundation for post-market surveillance.
Deliverable Outcome
- Clinical evaluation plan (CEP)
- CER/PER writing and structuring
- Literature review methodology
- Equivalence assessment and justification
Risk Management File
ISO 14971 compliance for technical documentation
What This Means For You
Integrate risk management throughout your technical documentation. A complete risk management file demonstrates that all foreseeable risks have been identified, evaluated, and controlled to acceptable levels.
Deliverable Outcome
- Risk management plan and report
- Hazard identification and risk assessment
- Risk control verification
- Residual risk evaluation and benefit-risk analysis
Labelling, IFU & UDI (EU)
MDR/IVDR Annex I Chapter III compliance
What This Means For You
Ensure safe and effective use through compliant labeling. Proper IFU content, symbols, and UDI implementation reduce use errors, support traceability, and demonstrate compliance with essential requirements.
Deliverable Outcome
- IFU content development and review
- EU UDI assignment and EUDAMED registration
- Label design and symbol compliance
- Translation and localization strategy
CE Marking Achievement & Post-Market Compliance
We facilitate your interactions with Notified Bodies during conformity assessment procedures and help establish effective Post-Market Surveillance (PMS), Post-Market Clinical Follow-up (PMCF), and Vigilance systems essential for maintaining your CE mark in the EU.
Notified Body Strategy
Selection and relationship management
What This Means For You
Partner with the right Notified Body for your device and business needs. Strategic selection and proactive relationship management smooth the certification process and set the foundation for ongoing compliance.
Deliverable Outcome
- Notified Body capability assessment
- Application package preparation
- Communication strategy and templates
- Contract and scope negotiation support
Audit Preparation
Conformity assessment readiness
What This Means For You
Enter audits confident and prepared. Systematic preparation reduces findings, shortens certification timelines, and demonstrates your organization's commitment to quality and compliance.
Deliverable Outcome
- Mock audit execution and gap closure
- Evidence package organization
- Auditee training and coaching
- Opening/closing meeting preparation
PMS System Setup
Post-Market Surveillance planning and implementation
What This Means For You
Transform post-market data into competitive advantage. A well-designed PMS system not only ensures regulatory compliance but provides valuable insights for product improvement and market positioning.
Deliverable Outcome
- PMS plan development
- Data collection and analysis procedures
- PSUR preparation framework
- Trend reporting methodology
Vigilance & PMCF
Incident reporting and proactive data collection
What This Means For You
Stay ahead of safety issues with robust vigilance and PMCF. Timely reporting and proactive clinical follow-up protect patients, satisfy regulators, and generate valuable real-world evidence.
Deliverable Outcome
- Vigilance procedure and reporting workflows
- PMCF plan and evaluation report
- Incident investigation templates
- Field Safety Corrective Action (FSCA) protocols
Ready to bring your MedTech innovation to the EU market? Let's simplify your regulatory pathway.