ELLECOM
Fletcher Landgoed Hotel Avegoor
Fletcher Landgoed Hotel Avegoor is a characteristic hotel in Ellecom, uniquely situated in the Veluwe region near Arnhem. It offers a pleasant stay with various facilities, including a sauna, indoor pool, and versatile meeting rooms, perfect for both leisure and business.
Fletcher Landgoed Hotel Avegoor is a distinctive hotel nestled in Ellecom, uniquely positioned in the heart of the Veluwe and close to the vibrant city of Arnhem. This historic estate provides an ideal setting for a memorable stay, whether you're seeking a weekend of nature and culture or a special event. The hotel boasts a range of amenities designed for relaxation and enjoyment. Guests can unwind in the sauna or take a dip in the indoor swimming pool. For those planning business meetings or celebrations, the hotel offers well-equipped, multifunctional conference rooms. The culinary experience at Fletcher Landgoed Hotel Avegoor is centered around its atmospheric restaurant. Here, guests can savor delicious dishes prepared by the chef and his team, with a focus on honest food and regional products. The surrounding area offers numerous excursion opportunities, including the beautiful nature reserves of the IJssel Valley and the Veluwe, as well as the nearby city of Arnhem for day trips.
About
**Who they are**
ELLECOM is a strategic partner for companies across various industries, specializing in regulatory solutions and market access for medical devices and IVDs. They operate with three core business areas: Regulatory Affairs, Trade of Medical Devices, and Electronic Components.
**Expertise & scope**
* Support for EU regulations, specifically MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation).
* Assistance with implementing ISO standards.
* Guidance on CE marking and ISO certification processes.
* Services related to the registration of medical devices and IVDs under MDR/IVDR.
* Expertise in Basic UDI-DI and SRN (Single Registration Number) requirements.
* Consultation on the transition from MDD/IVDD certifications to MDR/IVDR.
**Reputation / proof points**
* International team with high competence in regulatory matters, procurement, and trade.
ELLECOM is a strategic partner for companies across various industries, specializing in regulatory solutions and market access for medical devices and IVDs. They operate with three core business areas: Regulatory Affairs, Trade of Medical Devices, and Electronic Components.
**Expertise & scope**
* Support for EU regulations, specifically MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation).
* Assistance with implementing ISO standards.
* Guidance on CE marking and ISO certification processes.
* Services related to the registration of medical devices and IVDs under MDR/IVDR.
* Expertise in Basic UDI-DI and SRN (Single Registration Number) requirements.
* Consultation on the transition from MDD/IVDD certifications to MDR/IVDR.
**Reputation / proof points**
* International team with high competence in regulatory matters, procurement, and trade.
Additional information
ELLECOM emphasizes a comprehensive approach to regulatory compliance, particularly concerning the transition from older directives (MDD/IVDD) to the newer EU regulations (MDR/IVDR). They highlight that products certified under MDD or IVDD require re-evaluation under MDR/IVDR, with timelines dependent on the original certification date. Their services are designed to address these complex compliance pathways, ensuring clients can navigate market access requirements effectively.
Key Highlights
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Provides regulatory solutions and market access support for medical devices and IVDs.
Source
“Leistungen für Medizinprodukte und IVD”
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Assists with implementing ISO standards and navigating CE marking.
Source
“Wir helfen ISO Standards zu implementieren; CE Kennzeichnung”
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Expertise in EU regulations MDR and IVDR, including device and actor registration.
Source
“gemäß der EU Verordnungenzu MDR und IVDR; Leistungen für Medizinprodukte und IVD”
Certifications & Trust Signals
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International team with high competence in regulatory topics, procurement, and trade.
Source
“Unser internationales Team mit hoher Kompetenz für regulatorische Themen sowie Beschaffung und Handel”
Buyer Snapshot
Best for
- Companies needing support with EU MDR and IVDR compliance.
- Manufacturers transitioning from MDD/IVDD to MDR/IVDR.
How engagement typically works
- Personalized consultation and expert support.
- Strategic partnership across regulatory and trade functions.
Typical deliverables
- Regulatory strategy and implementation guidance.
- Support for device and actor registration.
- Assistance with CE marking and ISO certification.
Good to know
- Best when requiring specialized knowledge of EU medical device regulations.
HQ:
Ellecom, Netherlands
Languages:
English, German, French
Timezones:
CET, GMT
Status:
listed
Services & Capabilities
EUDAMED Onboarding & Data Registration Support (Mandatory Modules)
Jurisdictions:
EU
Countries:
Germany, France, UK
Industries:
Medical Devices, IVD
Pricing model:
Per project
Modules Supported:
Actor/SRN, UDI/Devices, Certificates, Market Surveillance
Submission Approach:
Portal, Bulk Submissions, M2M Integration
Portfolio Fit:
1-5
Onboarding Speed:
1-2 weeks
Managed Service Available:
Yes
Integration Support:
ERP/PLM mapping, Labeling mapping, Access point onboarding
Additional eudamed_onboarding_support Details
Modules Supported
Actor/SRN, UDI/Devices, Certificates (implied by MDR/IVDR support)
Submission Approach
Portal operations (implied by SRN and device registration support)
