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. The company was formed through the merger of MDR Regulator and a clinical research team.
**Expertise & scope**
* Accelerating innovation from concept to patient by combining expertise in design, clinical research, certification, and post-market surveillance.
* Providing support for MDR and IVDR compliance, including regulatory interpretation, certification strategy, and execution speed.
* Offering guidance on PRRC responsibilities, including technical documentation, post-market surveillance, vigilance, and regulatory interactions.
* Specializing in clinical trials, including design, IVD performance studies, feasibility assessment, site selection, trial monitoring, data management, statistical analysis, and medical writing.
**Reputation / proof points**
* Over 500 projects completed.
* 230 certifications achieved.
* Clients from 37 markets.
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. The company was formed through the merger of MDR Regulator and a clinical research team.
**Expertise & scope**
* Accelerating innovation from concept to patient by combining expertise in design, clinical research, certification, and post-market surveillance.
* Providing support for MDR and IVDR compliance, including regulatory interpretation, certification strategy, and execution speed.
* Offering guidance on PRRC responsibilities, including technical documentation, post-market surveillance, vigilance, and regulatory interactions.
* Specializing in clinical trials, including design, IVD performance studies, feasibility assessment, site selection, trial monitoring, data management, statistical analysis, and medical writing.
**Reputation / proof points**
* Over 500 projects completed.
* 230 certifications achieved.
* Clients from 37 markets.
Additional information
Pure Clinical emphasizes a collaborative approach, working *with* companies rather than *for* them, understanding that product success hinges on clinical data, precise regulatory interpretation, and certification speed. They leverage their experience from both institutional and operational sides of MDR and IVDR to advise proactively. Their team comprises professionals with prior experience in assessing technical documentation for notified bodies, leading clinical investigations, and implementing quality systems for global manufacturers, ensuring a complete view of the product lifecycle from study design to certification audit. They aim to streamline processes, reduce risks, and deliver documentation that achieves first-time approval.
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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Over 500 projects completed and 230 certifications achieved.
Source
“Our partnership is a measurable advantage: over 500 projects, 230 certifications, and clients from 37 markets.”
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The PRRC role is mandatory for medical device and IVD manufacturers under MDR and IVDR.
Source
“The Person Responsible for Regulatory Compliance (PRRC) is a mandatory role for all medical device and IVD manufacturers under MDR and IVDR – ensuring legal compliance of the product throughout its entire lifecycle.”
Certifications & Trust Signals
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Team comprises professionals with experience from notified bodies and competent authorities.
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.”
Buyer Snapshot
Best for
- Manufacturers, importers, and distributors of medical devices and IVDs
- Companies developing technologies that move faster than regulations
- Organizations seeking to anticipate regulatory changes
How engagement typically works
- Partnership-focused, co-creation
- Direct access to experts with proven MedTech experience
- Tailored collaboration models
Typical deliverables
- MDR/IVDR compliance strategies
- Certification and market access support
- Clinical trial design and management
- PRRC services
- Post-market surveillance support
Good to know
- Best when seeking proactive regulatory guidance and accelerated market entry without compromising compliance.
HQ:
Dublin, Ireland
Languages:
English
Timezones:
Europe/Dublin
Claim 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 may include CVs, role descriptions, contracts, and evidence of regulatory competence per MDCG 2019-7.
Regulatory Experience
Extensive experience derived from assessing technical documentation within notified bodies, leading clinical investigations, and implementing quality systems for global manufacturers. Expertise covers the entire product lifecycle from study design to certification audit.
