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Everything Your Device Needs to Reach Market

We cover the full medical device lifecycle across the US, EU, and major global markets. If you do not see your specific need, reach out - most engagements start with a conversation.

RAi

Want to automate your regulatory submissions?

RAi is our AI platform that drafts 510(k)s, scores regulatory risk, manages your QMS, and maintains Part 11 audit trails.

Explore RAi
Research and Development Support
User needs research, contextual inquiry, voice-of-customer studies
Clinical workflow analysis and unmet need validation
Indications for use, intended use, and product requirements / design inputs
Feasibility studies, proof-of-concept testing, technology readiness
Make-vs-buy analysis, IP landscape, freedom-to-operate
Regulatory pathway impact on design decisions
Mechanical, electrical, and software architecture review
Design for Manufacturing, Assembly, Reliability, Service, Sustainability
Materials selection for biocompatibility and component qualification
Combination product co-development (drug-device, biologic-device)
Design and Development Plan authoring and design input traceability
Design History File authoring, audit, remediation, and legacy DHF reconstruction
US FDA Regulatory
510(k) - Traditional, Special, and Abbreviated submissions
De Novo classification requests
Investigational Device Exemption (IDE)
Humanitarian Device Exemption (HDE)
Premarket Approval (PMA) and PMA supplements
Pre-Submission (Q-Sub) meetings and study risk determinations
Safer Technologies Program (STeP) and Breakthrough Device Designation
513(g) requests for classification information
UDI and GUDID submissions
FDA establishment registration and device listing
FDA response strategy and deficiency letter management
Pre-submission meeting prep and FDA coaching
EU and International Markets
EU MDR 2017/745 - Technical documentation and clinical evaluation
IVDR 2017/746 - In vitro diagnostic device submissions
Notified Body engagement and audit preparation
CE Mark strategy and legacy device transition planning
Health Canada medical device submissions
TGA (Australia), PMDA (Japan), NMPA (China) regulatory strategy
MDR/IVDR Post-Market Surveillance and PMCF planning
EUDAMED registration and UDI-DI assignment
Verification and Validation
V&V master plan authoring and test protocol development
Bench testing design, execution oversight, and report authoring
Biocompatibility testing strategy (ISO 10993)
Sterilization validation - EO, radiation, steam
Shelf life and accelerated aging studies
Usability engineering and summative human factors studies (IEC 62366)
Process validation - IQ, OQ, PQ
Software verification and validation (IEC 62304)
Quality Management Systems
ISO 13485:2016 QMS implementation and gap analysis
QMSR (21 CFR 820) implementation - harmonized with ISO 13485
FDA inspection preparation and 483 response strategy
Warning Letter remediation and Consent Decree support
CAPA system design, investigation, and effectiveness verification
Supplier qualification, audit, and ongoing monitoring
Document control and change management systems
Internal audit programs and management review facilitation
Risk Management and Human Factors
ISO 14971 risk management file creation and review
Fault tree analysis, FMEA, and hazard analysis
IEC 62366 usability engineering and HF validation
FDA human factors submission preparation
Risk-benefit analysis for novel and high-risk devices
Software, AI/ML and Cybersecurity
SaMD regulatory strategy and classification (FDA, IMDRF, EU MDR)
IEC 62304 software lifecycle documentation
AI/ML PCCP (Predetermined Change Control Plan) development
FDA cybersecurity submissions (510(k), PMA, De Novo)
SBOM (Software Bill of Materials) development
IoMT and connected device regulatory architecture
21 CFR Part 11 electronic records and signatures compliance
Clinical and Post-Market
Clinical Evaluation Reports (CER) for EU MDR
IDE applications and clinical study design
ISO 14155 Good Clinical Practice for medical devices
Post-Market Clinical Follow-up (PMCF) plans and reports
Real-world evidence strategy for label expansion
Medical Device Reporting (MDR) and vigilance reporting
Post-market surveillance system design
Remediation, Expert Witness and M&A
FDA 483 response and Warning Letter remediation
Consent Decree support and remediation planning
Expert witness testimony - regulatory and quality matters
Regulatory due diligence for M&A transactions
Technical investment review for medical device portfolios

Do not see exactly what you need?

Most engagements start with a conversation. A free 20-minute call is enough to figure out the right path forward.

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