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**
* Leverages unequalled team knowledge and expertise.
* Has a track record of audit success for their clinical evaluation process.
* Can deliver a first draft of the CER within 6 weeks.
* Utilizes experts in regulatory, systematic review researchers, and medical writers, investing in systematic review software and NICE validated tools.
* Access to medical key opinion leaders, researchers, medical writers, regulatory consultants, toxicologists, and biostatisticians.
* Has access to all medical specialties in the UK and Europe for connecting manufacturers to end-users and research networks for PMCF data collection.
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**
* Leverages unequalled team knowledge and expertise.
* Has a track record of audit success for their clinical evaluation process.
* Can deliver a first draft of the CER within 6 weeks.
* Utilizes experts in regulatory, systematic review researchers, and medical writers, investing in systematic review software and NICE validated tools.
* Access to medical key opinion leaders, researchers, medical writers, regulatory consultants, toxicologists, and biostatisticians.
* Has access to all medical specialties in the UK and Europe for connecting manufacturers to end-users and research networks for PMCF data collection.
Additional information
Clin-R+ emphasizes a collaborative approach, bringing key opinion leaders, researchers, medical writers, regulatory consultants, toxicologists, and biostatisticians to supplement existing teams. They invest in systematic review software and validated tools to streamline workflows, enabling real-time online collaboration with clients for swift progress. Flexibility and advisory support are provided to address any gaps in knowledge or resources. Their services are designed to ensure audit and inspection readiness for clients.
Key Highlights
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Specializes in Medical Device and IVD regulatory affairs, clinical evaluation, and technical documentation.
Source
“CLIN-r+ is a specialist Medical Device consultancy providing regulatory affairs, clinical evaluation, and technical documentation services for MedTech and IVD manufacturers worldwide.”
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Offers rapid development of Clinical Evaluation Reports (CERs), with a first draft deliverable in as little as 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 comprehensive support for EU MDR and IVDR Technical Documentation.
Source
“Technical Documentation For EU MDR IVDR Technical Documentation”
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Leverages extensive expertise by integrating key opinion leaders, researchers, and medical writers into client projects.
Source
“To ensure rapid success, we bring medical key opinion leaders, researchers, medical writers, regulatory consultants, toxicologists and biostatisticians to your team to supplement the know-how of your existing teams.”
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.””
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Ensures clients remain in compliance with regulatory standards and provides audit and inspection readiness.
Source
“We ensure our clients remain in compliance with regulatory standards. Our clinical, IVD, and technical documentation services provide audit and inspection readiness”
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 navigating EU MDR and IVDR requirements.
How engagement typically works
- Collaborative, supplementing existing teams with specialized expertise.
- Data-driven solutions and advisory support.
- Real-time online collaboration for efficient project progress.
Typical deliverables
- Clinical Evaluation Reports (CERs)
- Technical Documentation (EU MDR, IVDR)
- Post-Market Surveillance (PMS) plans
- Post-Market Clinical Follow-up (PMCF) Plans
- Biocompatibility Evaluations
- Quality Management System (QMS) Remediation
Good to know
- Best when manufacturers require specialized regulatory, clinical, and technical documentation expertise.
- Ideal for companies aiming for rapid CER development (first draft within 6 weeks).
HQ:
London, GB
Languages:
English
Timezones:
Europe/London
Claim status:
Listed
Services & Capabilities
Find PRRC Services | EU MDR/IVDR Providers & 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
The website mentions collaboration done real-time online with clients and providing flexibility and advisory support in case of gaps, suggesting an integrated and responsive onboarding process.
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. Jacqueline van Druten (MICR.CIM.RD) leads the team as Clinical & Regulatory Affairs Director.
Regulatory Experience
Over 20 years of technical writing experience is mentioned. The company was founded with a specific objective related to patient safety and device effectiveness.
