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 is a provider of medical services, offering a range of healthcare solutions and compliance consulting. They assist companies in developing safe medical products and achieving marketing objectives throughout the entire product quality life cycle.
**Expertise & scope**
* Assistance with CE Marking and the MDR.
* Support for Risk Assessment under the MDR.
* Guidance on Biological Evaluation.
* Validation of Processes, Test Methods, and Software.
* Support for Clinical Evaluation and Investigation.
* Assistance with FDA Approval.
* Assistance with CFDA Approval.
* Certification for IVD Medical Devices, including In Vitro Diagnostics and the IVDR.
**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 is a provider of medical services, offering a range of healthcare solutions and compliance consulting. They assist companies in developing safe medical products and achieving marketing objectives throughout the entire product quality life cycle.
**Expertise & scope**
* Assistance with CE Marking and the MDR.
* Support for Risk Assessment under the MDR.
* Guidance on Biological Evaluation.
* Validation of Processes, Test Methods, and Software.
* Support for Clinical Evaluation and Investigation.
* Assistance with FDA Approval.
* Assistance with CFDA Approval.
* Certification for IVD Medical Devices, including In Vitro Diagnostics and the IVDR.
**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 helping companies, both large and small, successfully bring their medical device and IVD products to market. Their approach involves expert regulatory services and strategies applied throughout the product life-cycle. They pride themselves on extensive experience, effective project management, and cost-effectiveness, positioning their solutions as a strong combination for various company sizes. GemarMed aims to solve problems sustainably and works in a precise, fast, and structured manner, emphasizing competence and excellence.
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
“Around the globe, Gemarmed assists companies both large and small to successfully develop and bring their medical device and IVD products to the market, 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 help our clients maximize the value of their products”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Companies seeking assistance with medical device and IVD product development and market entry.
- Businesses needing regulatory compliance consulting throughout the product life cycle.
How engagement typically works
- Collaborative, focusing on tailored solutions.
- Structured and precise approach to problem-solving.
Typical deliverables
- Regulatory strategy development.
- Support for CE Marking and FDA/CFDA approvals.
- Risk assessment and biological evaluation services.
- Clinical evaluation and investigation support.
Good to know
- Best when clients require specialized expertise in medical device and IVD regulations.
HQ:
Valencia, Spain
Languages:
English, Spanish
Timezones:
Europe/Madrid
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:
Class I, Class Is/Im/Ir, Class IIa, Class IIb, Class III, 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.
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 CE Marking and MDR services)
Supports IVDR
Yes
PRRC Qualification Summary
Team includes professionals with documented experience and former officials of Notified Body TÜV SÜD Product Service, and GxP Quality System auditors.
Regulatory Experience
Extensive experience in regulatory services and strategies throughout the product life-cycle.
