Clin-R
CLIN-r+
CLIN-r+ is a specialist Medical Device consultancy providing regulatory affairs, clinical evaluation, and technical documentation services for MedTech and IVD manufacturers worldwide. They ensure compliance and facilitate market access.
CLIN-r+ is a specialist Medical Device consultancy focused on Medical Affairs, Regulatory, and Assurance for Medical Devices and In Vitro Diagnostics. They offer a comprehensive suite of services designed to help manufacturers navigate complex regulatory landscapes and achieve market compliance. Their expertise includes Clinical Evaluation Reports (CER), Biocompatibility Evaluations, Post Market Surveillance, Technical Documentation for EU MDR and IVDR, and Regulatory Affairs Management. CLIN-r+ leverages its team's extensive knowledge and experience to provide data-driven solutions, ensuring clients remain compliant with evolving regulatory standards and achieve audit and inspection readiness. With a commitment to patient safety and access to effective medical devices, CLIN-r+ partners with manufacturers to overcome challenges in bringing new technologies to market. They facilitate connections with medical key opinion leaders, researchers, and regulatory consultants to supplement existing teams and accelerate innovation. CLIN-r+ operates globally, offering flexible advisory support and aiming to deliver first drafts of CERs within 6 weeks.
About
**Who they are**
Clin-R+ is a specialist Medical Device consultancy focused on regulatory affairs, clinical evaluation, and technical documentation for MedTech and IVD manufacturers globally. They aim to ensure compliance and facilitate market access.
**Expertise & scope**
* Regulatory Affairs Management
* Systematic Literature Reviews (SLR) for State of the Art, Safety, and Performance Data
* Clinical Evaluation Reports (CER)
* Post-Market Surveillance (PMS) and Quality Management System (QMS) Remediation
* Clinical and Technical Documentation (including for EU MDR and IVDR)
* Post-Market Clinical Follow-up (PMCF) Plans and Statistical Analysis Plans (SAP)
* Validation Project Management
* Quality and Validation
* Biocompatibility Evaluations
**Reputation / proof points**
* Access to medical key opinion leaders, researchers, regulatory consultants, toxicologists, and biostatisticians.
* Over 20 years of collective technical writing experience.
* Capability to deliver a first draft of a CER within 6 weeks.
* Utilizes systematic review software and NICE validated tools.
* Access to all medical specialties in the UK and Europe for connecting manufacturers with end-users and research networks.
Clin-R+ is a specialist Medical Device consultancy focused on regulatory affairs, clinical evaluation, and technical documentation for MedTech and IVD manufacturers globally. They aim to ensure compliance and facilitate market access.
**Expertise & scope**
* Regulatory Affairs Management
* Systematic Literature Reviews (SLR) for State of the Art, Safety, and Performance Data
* Clinical Evaluation Reports (CER)
* Post-Market Surveillance (PMS) and Quality Management System (QMS) Remediation
* Clinical and Technical Documentation (including for EU MDR and IVDR)
* Post-Market Clinical Follow-up (PMCF) Plans and Statistical Analysis Plans (SAP)
* Validation Project Management
* Quality and Validation
* Biocompatibility Evaluations
**Reputation / proof points**
* Access to medical key opinion leaders, researchers, regulatory consultants, toxicologists, and biostatisticians.
* Over 20 years of collective technical writing experience.
* Capability to deliver a first draft of a CER within 6 weeks.
* Utilizes systematic review software and NICE validated tools.
* Access to all medical specialties in the UK and Europe for connecting manufacturers with end-users and research networks.
Additional information
Clin-R+ emphasizes a collaborative approach, bringing their team's expertise to supplement existing client teams. They facilitate real-time online collaboration for swift progress on projects. Their services are designed to provide audit and inspection readiness. For clinical evaluations, they leverage a multi-disciplinary approach, gathering expertise from various medical specialties to ensure comprehensive documentation. They also support manufacturers in navigating MDD to MDR migrations and Health Technology Assessments.
Key Highlights
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Specialist consultancy for Medical Devices and In Vitro Diagnostics.
Source
“CLIN- r+ is a specialist Medical Affairs, Regulatory and Assurance consultancy in Medical Devices and In Vitro Diagnostics.”
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Expertise in EU MDR and IVDR Technical Documentation.
Source
“Technical Documentation For EU MDR IVDR Technical Documentation”
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Can deliver a first draft of a Clinical Evaluation Report (CER) within 6 weeks.
Source
“So it comes as no surprise that our first draft of the CER can be delivered within 6 weeks* to our clients.”
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Access to a wide network of medical specialists and key opinion leaders.
Source
“CLIN-r+ has access to all medical specialties in UK and Europe to help manufacturers connect to end users and research networks”
Certifications & Trust Signals
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Founded with the objective to ensure patients have access to safe and effective medical devices and in vitro diagnostics.
Source
“CLIN-r+ was founded with a single objective in mind: “to ensure that patients have access to safe and effective medical devices and in vitro diagnostics.””
Buyer Snapshot
Best for
- Medical device and IVD manufacturers seeking regulatory compliance and market access.
- Companies needing support with Clinical Evaluation Reports (CERs) and Technical Documentation.
- Manufacturers undergoing MDD to MDR migration.
How engagement typically works
- Collaborative, supplementing existing teams with specialized expertise.
- Real-time online collaboration for efficient project management.
- Advisory support and flexibility to address knowledge gaps.
Typical deliverables
- Clinical Evaluation Reports (CERs)
- Technical Documentation Packages (EU MDR/IVDR)
- Post-Market Surveillance (PMS) plans and reports
- Post-Market Clinical Follow-up (PMCF) Plans
- Biocompatibility Evaluations
- Quality Management System (QMS) remediation
Good to know
- Best when manufacturers require specialized regulatory and clinical affairs expertise for complex medical devices and IVDs.
- Ideal for companies needing to ensure compliance with EU MDR and IVDR.
HQ:
London, GB
Languages:
English
Timezones:
Europe/London
Claim status:
Listed
Services & Capabilities
PRRC MDR (EU MDR) | PRRC Medical Device Service | Compare Providers & Get Quotes
Jurisdictions:
EU
Countries:
GB, EU
Industries:
Medical devices, IVD, SaMD, Manufacturing
Portfolio:
1-5
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Starting from:
GBP 1,200
Included services:
PRRC appointment support, Lifecycle compliance oversight, Change-impact escalation, PMS/vigilance coordination support
Device Classes Supported:
Class I, Class Is/Im/Ir, Class IIa, Class IIb, Class III, IVD
PRRC Qualification Summary:
The company's team consists of medical professionals, seasoned Medical Device developers, regulatory consultants, researchers, and biostatisticians. Jacqueline van Druten, Clinical & Regulatory Affairs Director, leads the team.
Named PRRC:
No
Additional prrc_service Details
Included Services Detailed
Appointment and mandate support for outsourced PRRC coverage (seed scope), Lifecycle compliance oversight aligned to Article 15 activities (seed scope), Change-impact triage and escalation support (seed scope), Periodic compliance reporting to management (seed scope)
Excluded Services
Notified Body decision-making on conformity assessment, Acting as Legal Manufacturer unless separately contracted, Commercial distribution or importer/distributor operations
Onboarding Steps
Collaboration of key inputs is done real time online with clients ensuring swift progress. Flexibility and advisory support is also provided in the case of gaps.
Coverage Details
PRRC availability set to Custom with defined escalation path (seed summary).
Device Classes Supported
All classes
Supports MDR
Yes
Supports IVDR
Yes
PRRC Qualification Summary
The company consists of Medical, Regulatory, QA Engineering, and Research professionals. Their Clinical Affairs teams include medical professionals and seasoned Medical Device developers. They bring in medical key opinion leaders, researchers, medical writers, regulatory consultants, toxicologists, and biostatisticians.
Regulatory Experience
Over 20 years of collective technical writing experience. Expertise in regulatory affairs, clinical evaluation, and technical documentation for medical devices and IVDs.
