Clinical Evaluation & regulatory workflow
right the first time
At CLIN-r+ we’re a trusted Clinical Regulatory affairs partner to manufacturers of medical and in-vitro diagnostics devices manufacturers worldwide. We ensure our clients remain in compliance with regulatory standards. Our clinical, IVD, and technical documentation services provide audit and inspection readiness
MedTech Academy
All things Medical Device and IVD development. At CLIN-r+ we believe in sharing knowledge so that manufacturers and innovators can bring great technology to healthcare
Top MDR Submission Feedback
Biocompatibility
Clinical Regulatory Affairs – Consultancies vs Agencies
Medical Device Non Conformances
Toxicological Risk Assessment and Biological Evaluation
Gap Assessment
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CLINr+ Services
Medical Device Clinical Development planning
We offer a team of seasoned experts to support the strategic planning of the development of your device. This service provides the master roadmap to develop and get CE accreditation for your Medical Device. Deliverables include:
- Gap Assessment
- Clinical Development Plan
- Device Classification Checklist
- CE marking conformity requirements example GSPR checklist & matching Validation Master plan
- QMS system remediation needs for audit readiness
Clinical and Technical documentation
We offer essential services to address important areas of technical and clinical documentation, including:
- Risk Management
- Usability Engineering
- Health Hazard (HHA) and Benefit Risk Analysis
- QMS system procedures and more...
Quality and Validation
We offer a broad range of services to address essential areas of technical and clinical documentation, including:
- Identification of Common Standards for conformity
- Identifying Verification testing needs
- Biocompatibility Evaluation
- Usability Plans
- Validation and more..
Clinical Evaluation Reports & Review
Our clinical evaluation approach has verified audit success. This has been further enhanced with agile live project management to assure 6 weeks turnaround with highly skilled medical writers and clinicians reviewing your SoTA. Deliverables include:
- Indentification of Common Standards for conformity
- Intended Purpose and MDR terms translation and remediation
- Clinical Evaluation Gap Assessment
- Clinical Evaluation Plan (CEP)
- Clinical Evaluation Report (CER)
- State of the Art (SOTA)
- Clinical Evaluation Assessment Report (CEAR)
- Clinical evaluation remdiation
Project Management of Verification & Validation outsourcing
Need help to identify, project plan and outsource your validation planning. Unsure who to contract in? Our project leaders have years of experience in medical device validation and contracting with testing houses. We offer a broad range of project management services and work with the top testing houses to ensure this gets done on time, on budget and aligns with your conformity strategy for CE marking including:
- Validation Master Plan (VMP)
- Validation Master Report (VMR)
- Testing protocol review and validation
- Selection and Validation of Third Party Testing Houses for QMS
- Article Summaries with GSPR and MDCG Data Rank Summary
Safety & Performance Clinical Data
We help collect unbiased, independent assessment data x6 faster through Clinical Experience Activities that feed into Peer Review Publications to support their performance and safety clinical data. Our services include:
- Systematic Literature Reviews (SLR)
- SLR for target devices
- SLR for equivalent devices
- SLR for state of the art (SOTA)
- SLR reports
- Safety and Performance Endpoint data write-up
- Article Summaries with GSPR and MDCG Data Rank Summary
PMCF Plans & Surveys
Our team of clinical affairs consultants, clinical trial designers and biostatisticians ensure that not only are your clinical data gaps addressed, but your future claims designed into your PMCF studies in a cost-effective way. Medical Device Regulation requires a continual process known as post-market clinical follow-up (PMCF). Our services include:
- Clinical Investigation Plan (CIP)
- Clinical Investigation Report (CIR)
- SAP
- SAR
- Post Market Follow up (PMCF) Plan
- PMCF Checklist and Justification
In Vitro Diagnostic Regulation
We provide help and guidance in preparing your performance evaluation plan and reports to ensure that your in-vitro diagnostic medical device is in full compliance under IVDR. Services include:
- IVDR Technical Documentation
- Performance Evaluation Plan (PEP)
- Performance Evaluation Report (PER)
- Scientific, analytical and clinical performance
- Performance Evaluation Gap Assessment
- Post Market Surveillance (PMS) Plan
- Post Market Performance Follow up (PMPF) Plan
Regulatory Affairs Management
For Medical Device and Pharma companies, we offer project management and interim management services to ensure a holistic approach to their demands and particular business requirements.
