MEDAGENT
MEDAGENT GmbH
MEDAGENT offers expert services for medical device certification and compliance, guiding products from idea to market launch and beyond. With global offices, they ensure efficient and safe market entry.
MEDAGENT is your strategic partner for quality management, regulatory requirements, and process validation in the medical device sector. With over 25 years of experience, they provide expert guidance for efficient and safe market entry, covering the entire product lifecycle from initial concept through to post-launch market surveillance. Leveraging modern technologies and digital tools, MEDAGENT optimizes processes, enhances transparency, and improves collaboration. Their approach fosters seamless communication, rapid decision-making, and precise coordination for project success. They pride themselves on a partnership-based collaboration built on trust and transparency, aiming for long-term success. With a presence in Germany, the USA, Brazil, the UK, and Australia, MEDAGENT offers a highly qualified team and the necessary expertise for international market success. They are committed to providing tailored strategies and dedicated support for a smooth, compliant, and sustainable market positioning of your medical devices.
About
**Who they are**
MEDAGENT provides expert services for medical device certification and compliance. They guide products from initial concept through market launch and ongoing lifecycle management.
**Expertise & scope**
* Navigating medical device certification processes.
* Ensuring compliance for market entry.
* Supporting products from idea to market launch and beyond.
* Facilitating efficient and safe market entry.
**Reputation / proof points**
* Global offices ensuring broad reach.
* Coverage for the EU market.
MEDAGENT provides expert services for medical device certification and compliance. They guide products from initial concept through market launch and ongoing lifecycle management.
**Expertise & scope**
* Navigating medical device certification processes.
* Ensuring compliance for market entry.
* Supporting products from idea to market launch and beyond.
* Facilitating efficient and safe market entry.
**Reputation / proof points**
* Global offices ensuring broad reach.
* Coverage for the EU market.
Additional information
MEDAGENT's services are designed to streamline the complex journey of bringing medical devices to market. Their expertise spans the entire product lifecycle, from early-stage development to post-market surveillance. With a focus on global compliance, they assist clients in navigating diverse regulatory landscapes, ensuring that products meet all necessary standards for safe and efficient market entry. Their international presence with global offices helps facilitate this process across different regions.
Key Highlights
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Provides expert services for medical device certification and compliance.
Source
“MEDAGENT offers expert services for medical device certification and compliance, guiding products from idea to market launch and beyond.”
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Supports products from idea to market launch and beyond.
Source
“guiding products from idea to market launch and beyond.”
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Facilitates efficient and safe market entry with global offices.
Source
“With global offices, they ensure efficient and safe market entry.”
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Offers services covering the EU market.
Source
“Coverage: EU”
Certifications & Trust Signals
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Operates with global offices to ensure market access.
Source
“With global offices, they ensure efficient and safe market entry.”
Buyer Snapshot
Best for
- Medical device manufacturers seeking certification and compliance expertise.
- Companies aiming for efficient and safe market entry in the EU.
How engagement typically works
- Consultative approach to product development and compliance.
- End-to-end support from concept to market launch and beyond.
Typical deliverables
- Certification guidance and support.
- Compliance strategy development.
- Market entry facilitation.
Good to know
- Best when requiring specialized knowledge of medical device regulations for EU market entry.
HQ:
Mühlheim, DE
Languages:
English, German
Timezones:
Europe/Zurich
Status:
listed
Services & Capabilities
PRRC MDR (EU MDR) | PRRC Medical Device Service | Compare Providers & Get Quotes
Jurisdictions:
EU
Countries:
DE, US, BR, GB, AU, EU
Industries:
Medical devices, IVD, SaMD, Manufacturing
Portfolio:
26-100
Onboarding time:
3–14 days
Pricing model:
Onboarding + annual retainer
Starting from:
CHF 3,200
Included services:
PRRC appointment support, Lifecycle compliance oversight, Change-impact escalation, PMS/vigilance coordination support
Named PRRC:
Yes
Availability Hours:
Business hours
PRRC Qualification Summary:
MEDAGENT offers global compliance services including EU Authorized Representative, Responsible Person, Data Protection Officer, UK Responsible Person, Brazilian Registration Holder, U.S. Agent, and TGA Representative Australia. They have over 25 years of experience in medical device certification and approval, providing expert knowledge and practical solutions for international market access. They support clients from the initial idea through to market launch and beyond, ensuring smooth, compliant, and sustainable market positioning.
Device Classes Supported:
Class I, Class Is/Im/Ir, Class IIa, Class IIb, Class III, IVD
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
true
PRRC Qualification Summary
Expert services for medical device certification and compliance.
Regulatory Experience
Experience guiding products from idea to market launch and beyond.
