Medical Device Management (EU AR)
Baxter
Baxter is a global healthcare company dedicated to saving and sustaining lives through innovative medical devices and digital solutions. They offer a wide range of products and services across acute, nutritional, hospital, and surgical care.
Baxter is a leading global healthcare company with a long-standing commitment to saving and sustaining lives. For nearly a century, they have been at the forefront of healthcare innovation, developing products and technologies that enhance patient care and streamline clinical workflows. Their comprehensive portfolio includes solutions for acute, nutritional, hospital, and surgical care. Baxter is dedicated to helping healthcare professionals enhance their practice and improve patient experiences through connected devices and digitalized data sharing. They support various aspects of clinical practice, from physical exams and vital monitoring to specialized therapies. Baxter's innovations aim to speed patient recovery, reduce operating times, and improve overall patient outcomes. They personalize care solutions for patients in hospitals, ICUs, and at home, including specialized respiratory therapies designed for simplified delivery and improved mobility. The company is committed to advancing healthcare worldwide through its diverse range of products and services.
About
**Who they are**
Medical Device Management (EU AR) was founded in 2000 with the aim of assisting medical device companies in navigating regulatory requirements to bring their products to market. They focus on building long-term relationships with clients to address evolving regulatory challenges.
**Expertise & scope**
* EU Authorized Representative services from their Irish office.
* UK Responsible Person services from their UK office.
* Advice and support for implementing Quality Management Systems (QMS), including ISO 13485:2016 compliance.
* Guidance to achieve regulatory compliance, including CE marking, UKCA, MDR, and UDI.
* Manufacturing and testing of medical devices at their dedicated facility.
**Reputation / proof points**
* QMS certified to ISO 13485:2016.
* Established in 2000.
* Works with a client base ranging from start-ups to large multinationals.
* Serves clients across the EU and UK.
Medical Device Management (EU AR) was founded in 2000 with the aim of assisting medical device companies in navigating regulatory requirements to bring their products to market. They focus on building long-term relationships with clients to address evolving regulatory challenges.
**Expertise & scope**
* EU Authorized Representative services from their Irish office.
* UK Responsible Person services from their UK office.
* Advice and support for implementing Quality Management Systems (QMS), including ISO 13485:2016 compliance.
* Guidance to achieve regulatory compliance, including CE marking, UKCA, MDR, and UDI.
* Manufacturing and testing of medical devices at their dedicated facility.
**Reputation / proof points**
* QMS certified to ISO 13485:2016.
* Established in 2000.
* Works with a client base ranging from start-ups to large multinationals.
* Serves clients across the EU and UK.
Additional information
Medical Device Management (EU AR) tailors its support to meet specific client needs, offering services under a QMS certified to ISO 13485:2016. They assist in maintaining QMS up-to-date with the latest regulations and developments, and can help with notified body audits. Their client base encompasses a wide variety of medical devices, from nanoparticles to hospital beds and electronic monitors.
Key Highlights
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Provides EU Authorized Representative services from an Irish office.
Source
“we provide EU authorized representative services from our Irish office”
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Offers UK Responsible Person services from a UK office.
Source
“and UK responsible person services from our UK office”
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Expertise in ISO 13485:2016 compliance for Quality Management Systems.
Source
“advice and support on implementing quality management system. Including ISO 13485:2016 compliance”
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Assists with regulatory compliance including CE marking, UKCA, MDR, and UDI.
Source
“advice and support to achieve regulatory compliance including CE marking, UKCA, MDR and UDI”
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Established in 2000 to help medical device companies bring products to market.
Source
“Founded in 2000 Medical Device Management was established with the aim of assisting medical device companies”
Certifications & Trust Signals
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Quality Management System certified to ISO 13485:2016.
Source
“Our services are provided under our quality management system certified to ISO 13485:2016.”
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Operates from both an Irish office for EU representation and a UK office for UK representation.
Source
“we provide EU authorized representative services from our Irish office and UK responsible person services from our UK office”
Buyer Snapshot
Best for
- Companies seeking EU Authorized Representative services.
- Manufacturers needing UK Responsible Person services.
- Firms requiring assistance with QMS implementation and ISO 13485 compliance.
- Businesses navigating CE marking, UKCA, MDR, and UDI requirements.
How engagement typically works
- Long-term relationship focused.
- Tailored support based on client needs.
Typical deliverables
- EU Authorized Representative services.
- UK Responsible Person services.
- QMS implementation and maintenance guidance.
- Regulatory compliance advice (CE, UKCA, MDR, UDI).
- Manufacturing and testing services.
Good to know
- Best when requiring specific EU and UK regulatory representation and compliance support.
HQ:
Dublin, US
Languages:
English
Timezones:
Europe/Dublin
Status:
listed
Services & Capabilities
Best EU Authorized Rep (EC REP) | Compare & Get Quotes
Jurisdictions:
EU, UK
Countries:
IE, GB, DE, FR, NL
Industries:
Medical devices, IVD, Healthcare
Portfolio:
1-5, 6-25
Onboarding time:
3–21 days
Pricing model:
Onboarding + annual retainer
Starting from:
EUR 2,000
Included services:
EU Authorized Representative (EC REP) designation, Authority liaison and document availability support, Vigilance escalation and FSCA coordination, Labeling/EC REP identification review, Post-market support workflows (complaints, vigilance escalation)
Supports MDR:
Yes
Supports IVDR:
No
EU Entity Country:
Ireland
Can Be Named On Label:
Yes
Vigilance Contact Support:
Yes
Additional eu_ar Details
Supports MDR
true
EU Entity Country
Ireland
Supports IVDR
No
Fsca Recall Support
No
Post Market Support
No
Vigilance Contact Support
No
