GemarMed
GemarMed is a provider of medical services, offering a range of healthcare solutions. They are listed in the prrc_service directory.
GemarMed provides comprehensive medical services, aiming to deliver high-quality healthcare solutions. As a participant in the prrc_service directory, GemarMed is accessible to individuals seeking specialized medical assistance. Their commitment is to offer effective and patient-centered care, ensuring that clients receive the support they need for their health and well-being. Further details about their specific services and areas of expertise can be found through their official website and directory listings.
About
**Who they are**
GemarMed SRL is a consultancy that assists companies in developing safe medical products and achieving their marketing objectives. They offer compliance consulting services throughout the entire product quality life cycle.
**Expertise & scope**
* Expert regulatory services and strategies for medical device and IVD products.
* Support for CE Marking and the MDR (Medical Device Regulation).
* Assistance with Risk Assessment for the MDR.
* Guidance on Biological Evaluation.
* Support for Process, Tests Methods, and Software Validations.
* Services for Clinical Evaluation and Investigation.
* Support for FDA Approval.
* Support for CFDA Approval.
* Specialized services for In Vitro Diagnostics and the IVDR (In Vitro Diagnostic Regulation).
**Reputation / proof points**
* Professionals with documented experience and former officials of the Notified Body TÜV SÜD Product Service.
* GxP Quality System auditors are part of their team.
* Focus on developing innovative and cost-effective solutions tailored to client needs.
* Emphasis on honesty, transparency, and win-win cooperation.
GemarMed SRL is a consultancy that assists companies in developing safe medical products and achieving their marketing objectives. They offer compliance consulting services throughout the entire product quality life cycle.
**Expertise & scope**
* Expert regulatory services and strategies for medical device and IVD products.
* Support for CE Marking and the MDR (Medical Device Regulation).
* Assistance with Risk Assessment for the MDR.
* Guidance on Biological Evaluation.
* Support for Process, Tests Methods, and Software Validations.
* Services for Clinical Evaluation and Investigation.
* Support for FDA Approval.
* Support for CFDA Approval.
* Specialized services for In Vitro Diagnostics and the IVDR (In Vitro Diagnostic Regulation).
**Reputation / proof points**
* Professionals with documented experience and former officials of the Notified Body TÜV SÜD Product Service.
* GxP Quality System auditors are part of their team.
* Focus on developing innovative and cost-effective solutions tailored to client needs.
* Emphasis on honesty, transparency, and win-win cooperation.
Additional information
GemarMed focuses on providing expert regulatory services and strategies to help companies, both large and small, successfully bring their medical device and IVD products to market. Their approach involves developing innovative and cost-effective solutions, leveraging extensive experience and effective project management. They position themselves as problem solvers who work precisely, fast, and in a structured manner, aiming for excellence and focusing on their core competencies. Honesty, transparency, and appreciative communication are highlighted as essential elements of their client relationships.
Key Highlights
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Assists companies in developing safe medical products and achieving marketing objectives.
Source
“Help companies to develop safe medical products and achieve their marketing objectives, providing solutions and compliance consulting services, throughout the entire product quality life cycle.”
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Provides expert regulatory services and strategies for medical device and IVD products.
Source
“by providing expert regulatory services and strategies throughout the product life-cycle.”
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Team includes professionals with experience from Notified Body TÜV SÜD Product Service.
Source
“Professionals with documented experience and former officials of the Notified Body TÜV SÜD Product Service (TÜV PS) and GxP Quality System auditors”
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Offers support for CE Marking and compliance with the MDR and IVDR.
Source
“CE Marking and the MDR Risk Assessment the MDR In Vitro Diagnostics and the IVDR”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Companies seeking regulatory compliance consulting for medical devices and IVDs.
- Businesses needing support with CE Marking, MDR, and IVDR.
- Clients looking for expert guidance on product development lifecycle.
How engagement typically works
- Collaborative problem-solving.
- Structured and precise project execution.
- Focus on tailored, cost-effective solutions.
Typical deliverables
- Regulatory strategy development.
- Compliance consulting reports.
- Support for product certification processes (CE, FDA, CFDA).
Good to know
- Best when clients require specialized expertise in medical device and IVD regulations.
- Suitable for companies of all sizes, from small to large corporations.
HQ:
Valencia, Spain
Languages:
English, Spanish
Timezones:
Europe/Madrid
Claim status:
Listed
Services & Capabilities
PRRC MDR (EU MDR) | PRRC Medical Device Service | Compare Providers & Get Quotes
Jurisdictions:
EU
Countries:
EU, US, CN
Industries:
Medical devices, IVD, SaMD, Manufacturing
Portfolio:
1-5
Onboarding time:
7–30 days
Pricing model:
Custom pricing
Starting from:
EUR 1,200
Included services:
PRRC appointment support, Lifecycle compliance oversight, Change-impact escalation, PMS/vigilance coordination support
Device Classes Supported:
IVD
PRRC Qualification Summary:
Professionals with documented experience and former officials of the Notified Body TÜVSÜD Product Service (TÜVPS) and GxP Quality System auditors help our clients maximize the value of their products by developing innovative and cost-effective solutions, tailored to meet the needs and objectives of each and every client.
Named PRRC:
Yes
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 Custom with defined escalation path (seed summary).
Supports MDR
Yes
Device Classes Supported
Class I, IIa, IIb, III (implied by MDR/IVDR support)
Supports IVDR
Yes
PRRC Qualification Summary
Team includes professionals with documented experience and former officials of the Notified Body TÜV SÜD Product Service, as well as GxP Quality System auditors.
Regulatory Experience
Extensive experience in regulatory services and strategies for medical devices and IVDs, including CE Marking, MDR, IVDR, FDA, and CFDA approvals.
