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 with three business areas: Regulatory Affairs, Trade in Medical Devices, and Electronic Components. They offer expert advice and support from an international team highly competent in regulatory matters, procurement, and trade.
**Expertise & scope**
* Regulatory solutions and market access for medical devices and IVDs.
* Implementation of ISO standards.
* Support for MDR and IVDR compliance, including re-evaluation of products certified under MDD or IVDD.
* Trade in medical devices.
* Electronic components.
**Reputation / proof points**
* Specializes in regulatory affairs, trade in medical devices, and electronic components.
ELLECOM is a strategic partner with three business areas: Regulatory Affairs, Trade in Medical Devices, and Electronic Components. They offer expert advice and support from an international team highly competent in regulatory matters, procurement, and trade.
**Expertise & scope**
* Regulatory solutions and market access for medical devices and IVDs.
* Implementation of ISO standards.
* Support for MDR and IVDR compliance, including re-evaluation of products certified under MDD or IVDD.
* Trade in medical devices.
* Electronic components.
**Reputation / proof points**
* Specializes in regulatory affairs, trade in medical devices, and electronic components.
Additional information
ELLECOM focuses on navigating complex EU regulations such as the MDR and IVDR. They emphasize a tailored approach, addressing specific client inquiries and requirements. Their services extend to assisting with ISO standard implementation, crucial for market access. The company highlights its role in facilitating the transition for products previously certified under older directives (MDD/IVDD) to the newer MDR/IVDR frameworks, acknowledging that the timeline for this transition depends on the original certification date.
Key Highlights
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Provides regulatory solutions and market access for medical devices and IVDs.
Source
“Leistungen für Medizinprodukte und IVD”
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Assists with the implementation of ISO standards.
Source
“Wir helfen ISO Standards zu implementieren”
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Offers support for MDR and IVDR compliance.
Source
“gemäß der EU Verordnungenzu MDR und IVDR”
Certifications & Trust Signals
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Operates with three core business areas: Regulatory, Trade in Medical Devices, and Electronic Components.
Source
“Ellecom ist mit seinen drei Geschäftsbereichen Regulatorik, Handel mit Medizinprodukten und Elektronische Komponenten”
Buyer Snapshot
Best for
- Companies needing support with MDR and IVDR compliance.
- Businesses seeking assistance with ISO standard implementation.
- Organizations involved in the trade of medical devices.
How engagement typically works
- Personalized consultation.
- Expert advice and routine support.
Typical deliverables
- Regulatory strategy and market access guidance.
- ISO standard implementation support.
- MDR/IVDR compliance assistance.
- Medical device trade facilitation.
Good to know
- Best when requiring specialized regulatory support for medical devices and IVDs within the EU.
HQ:
Ellecom, Netherlands
Languages:
English, German, French
Timezones:
CET, GMT
Claim 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
Submission Approach:
Portal
Portfolio Fit:
1-5
Onboarding Speed:
1-2 weeks
Managed Service Available:
Yes
Integration Support:
ERP/PLM mapping
Additional eudamed_onboarding_support Details
Modules Supported
Actor/SRN, UDI/Devices
Submission Approach
Portal operations
⚡ Instant booking available
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