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 are dedicated to ensuring compliance and facilitating 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)
* Biocompatibility Evaluations
* Validation Project Management
* Quality and Validation
**Reputation / proof points**
* Founded with the objective to ensure patients have access to safe and effective medical devices and in vitro diagnostics.
* Access to medical key opinion leaders, researchers, medical writers, regulatory consultants, toxicologists, and biostatisticians.
* Access to all medical specialties in the UK and Europe for connecting manufacturers with end-users and research networks.
* Experience in supporting MDD to MDR migrations and Health Technology assessments.
* Can deliver a first draft of the CER within 6 weeks.
Clin-R+ is a specialist Medical Device consultancy focused on regulatory affairs, clinical evaluation, and technical documentation for MedTech and IVD manufacturers globally. They are dedicated to ensuring compliance and facilitating 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)
* Biocompatibility Evaluations
* Validation Project Management
* Quality and Validation
**Reputation / proof points**
* Founded with the objective to ensure patients have access to safe and effective medical devices and in vitro diagnostics.
* Access to medical key opinion leaders, researchers, medical writers, regulatory consultants, toxicologists, and biostatisticians.
* Access to all medical specialties in the UK and Europe for connecting manufacturers with end-users and research networks.
* Experience in supporting MDD to MDR migrations and Health Technology assessments.
* Can deliver a first draft of the CER within 6 weeks.
Additional information
Clin-R+ emphasizes their team's unequalled knowledge as a key strength, offering it to client projects. They utilize experts in regulatory affairs, systematic review research, and medical writing, investing in systematic review software and NICE-validated tools to streamline workflows. Collaboration is conducted in real-time online with clients to ensure swift progress, with flexibility and advisory support provided for any identified gaps. Their approach aims to bring medical key opinion leaders, researchers, medical writers, regulatory consultants, toxicologists, and biostatisticians to supplement existing teams' know-how.
Key Highlights
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Specializes in Medical Device and In Vitro Diagnostic regulatory affairs, clinical evaluation, and technical documentation.
Source
“CLIN-r+ is a specialist Medical Device consultancy of Medical, Regulatory, QA Engineering and Research professionals who specialise in creating compliant Technical Documents, SOP’s and CERs.”
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Can deliver a first draft of Clinical Evaluation Reports (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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Provides support for EU MDR and IVDR Technical Documentation.
Source
“Technical Documentation For EU MDR IVDR Technical Documentation”
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Access to a broad network of medical specialties across the UK and Europe.
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 support.
- Companies needing assistance with clinical evaluation and technical documentation.
- Manufacturers navigating EU MDR and IVDR requirements.
How engagement typically works
- Collaborative, real-time online engagement.
- Advisory support and flexibility for identified gaps.
- Supplementing existing client teams with specialized expertise.
Typical deliverables
- Clinical Evaluation Reports (CER)
- Technical Documentation (EU MDR/IVDR)
- Post-Market Surveillance (PMS) reports
- PMCF Plans and SAPs
- Biocompatibility Evaluations
Good to know
- Best when manufacturers require specialized regulatory and clinical affairs expertise to ensure compliance and market access.
HQ:
London, GB
Languages:
English
Timezones:
Europe/London
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
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
Contact CLIN-r+ to start a discussion about regulatory and quality needs. They offer a complimentary review.
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 is led by Jacqueline van Druten (MICR.CIM.RD), Clinical & Regulatory Affairs Director, who leads a team of consultants and advisors providing data-driven solutions.
Regulatory Experience
Over 20 years of technical writing experience mentioned. Expertise spans regulatory affairs, clinical evaluation, technical documentation, PMS, QMS remediation, and validation.
