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. They are listed in the prrc_service directory.

**Expertise & scope**
* Provider of medical services
* Offers a range of healthcare solutions

**Reputation / proof points**
* Coverage: EU
* Languages: English, Spanish

Additional information

GemarMed focuses on delivering a spectrum of medical services and healthcare solutions. Their operational scope includes coverage across the European Union, and they support communication in both English and Spanish. This provider is recognized within the prrc_service directory.

Key Highlights

  • 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.”
  • 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.”
  • 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”
  • 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

  • Registered office located in Medolla, Italy. Source
    “Registered Site: Via Bruino 100, I-41036 Medolla (Mo)”
  • Fiscal Code & VAT N. IT 03834470365 Source
    “Fiscal Code & Vat N. IT 03834470365 – Rea: MO – 421782”

Buyer Snapshot

Best for
  • Companies seeking medical service providers
  • Organizations requiring EU coverage
How engagement typically works
  • Service provision
  • Healthcare solutions
Typical deliverables
  • Medical services
  • Healthcare solutions
Good to know
  • Best when specific medical services or healthcare solutions are required within the EU.
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.
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