Pure Clinical
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About
**Who they are**
Pure Clinical Research and Development Center, established by experts from notified bodies, competent authorities, industry, and consulting, provides comprehensive support for medical device manufacturers, importers, and distributors. Founded through the merger of MDR Regulator and a clinical research team, they combine expertise in design, clinical research, certification, and post-market surveillance to accelerate innovation.
**Expertise & scope**
* Support for manufacturers, importers, and distributors of medical devices and IVDs.
* Expertise in clinical trials, including design, IVD performance studies, feasibility assessment, site selection, trial monitoring, data management, statistical analysis, and medical writing.
* Guidance on MDR and IVDR compliance, including PRRC responsibilities, technical documentation, post-market surveillance, vigilance, and regulatory interactions.
* Assistance with certification strategy and execution speed.
* Advising on regulatory interpretation and anticipating future regulatory changes.
**Reputation / proof points**
* Over 500 projects completed.
* 230 certifications achieved.
* Clients from 37 markets.
* Team comprises professionals with prior experience in notified bodies, clinical investigations, and quality system implementation for global manufacturers.
Pure Clinical Research and Development Center, established by experts from notified bodies, competent authorities, industry, and consulting, provides comprehensive support for medical device manufacturers, importers, and distributors. Founded through the merger of MDR Regulator and a clinical research team, they combine expertise in design, clinical research, certification, and post-market surveillance to accelerate innovation.
**Expertise & scope**
* Support for manufacturers, importers, and distributors of medical devices and IVDs.
* Expertise in clinical trials, including design, IVD performance studies, feasibility assessment, site selection, trial monitoring, data management, statistical analysis, and medical writing.
* Guidance on MDR and IVDR compliance, including PRRC responsibilities, technical documentation, post-market surveillance, vigilance, and regulatory interactions.
* Assistance with certification strategy and execution speed.
* Advising on regulatory interpretation and anticipating future regulatory changes.
**Reputation / proof points**
* Over 500 projects completed.
* 230 certifications achieved.
* Clients from 37 markets.
* Team comprises professionals with prior experience in notified bodies, clinical investigations, and quality system implementation for global manufacturers.
Additional information
Pure Clinical emphasizes a collaborative approach, working *with* clients rather than just *for* them. They leverage their experience from both institutional and operational sides of MDR and IVDR to proactively advise clients, aiming to streamline processes, reduce risks, and ensure documentation is approved efficiently. Their goal is to help clients not only navigate current regulations but also set industry benchmarks for future innovations. They offer tailored collaboration models to fit specific organizational needs, acting as a trusted partner from product concept to EU market access.
Key Highlights
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Pure Clinical was founded through the merger of MDR Regulator and a clinical research team.
Source
“Pure Clinical was founded through the merger of MDR Regulator – an organization shaping medical device compliance across Europe – and a research team conducting clinical and preclinical projects.”
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They have supported over 500 projects and achieved 230 certifications.
Source
“Our partnership is a measurable advantage: over 500 projects, 230 certifications, and clients from 37 markets.”
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Their team includes professionals who previously assessed technical documentation within notified bodies.
Source
“Our team is made up of professionals who once assessed technical documentation within notified bodies, led clinical investigations, and implemented quality systems for global manufacturers.”
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Pure Clinical provides support for PRRC compliance under MDR and IVDR.
Source
“How Pure Clinical supports manufacturers with PRRC compliance”
Certifications & Trust Signals
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Team members have experience assessing technical documentation within notified bodies.
Source
“Our team is made up of professionals who once assessed technical documentation within notified bodies...”
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They have experience leading clinical investigations.
Source
“...led clinical investigations, and implemented quality systems for global manufacturers.”
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They have experience implementing quality systems for global manufacturers.
Source
“...implemented quality systems for global manufacturers.”
Buyer Snapshot
Best for
- Medical device and IVD manufacturers seeking PRRC support.
- Companies needing assistance with MDR/IVDR compliance and certification.
- Organizations looking to accelerate innovation from concept to market.
How engagement typically works
- Collaborative partnership ('work with' model).
- Proactive advisory based on deep regulatory experience.
- Tailored collaboration models.
Typical deliverables
- PRRC appointment and ongoing support.
- Technical documentation review and preparation.
- Clinical trial design and management.
- Certification strategy and execution.
- Post-market surveillance guidance.
Good to know
- Best when seeking a partner with direct experience from regulatory bodies and industry.
HQ:
Dublin, Ireland
Languages:
English
Timezones:
Europe/Dublin
Status:
listed
Services & Capabilities
PRRC MDR (EU MDR) | PRRC Medical Device Service | Compare Providers & Get Quotes
Jurisdictions:
EU
Countries:
EU
Industries:
Medical devices, IVD, SaMD, Manufacturing
Portfolio:
6-25
Onboarding time:
5–21 days
Pricing model:
Retainer
Starting from:
EUR 1,800
Included services:
PRRC appointment support, Lifecycle compliance oversight, Change-impact escalation, PMS/vigilance coordination support
Named PRRC:
Yes
Availability Hours:
Custom
Device Classes Supported:
Class III, IVD
PRRC Qualification Summary:
The PRRC must meet the criteria set out in MDR and IVDR: Familiarity with ISO 14155 (clinical investigation) and ISO 14971 (risk management), clinical evaluation, and market surveillance processes is essential. In practice, documentation proving PRRC qualifications should be part of the QMS and include CVs, role descriptions, contracts, and evidence of regulatory competence per MDCG 2019-7. The PRRC is also responsible for correct EUDAMED data entries related to compliance and post-market surveillance under Articles 29 and 31 of MDR and IVDR.
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
Intake → scope & device class mapping → responsibilities matrix → workflow setup → ongoing PRRC coverage
Coverage Details
PRRC availability set to Business hours with defined escalation path (seed summary).
Device Classes Supported
Class I, IIa, IIb, III (implied by MDR/IVDR support)
Supports MDR
Yes
Supports IVDR
Yes
PRRC Qualification Summary
Familiarity with ISO 14971 (risk management), clinical evaluation, and market surveillance processes. Documentation proving qualifications should be part of the QMS and include CVs, role descriptions, contracts, and evidence of regulatory competence per MDCG 2019-7.
Regulatory Experience
Experience includes work with notified bodies, competent authorities, industry, and consulting. Specific years not stated, but implied extensive experience through project and certification counts.
