Company Tagline
Authorized Representative - EC REP / CH-REP / UK Responsible Person / U.S. Agent / Australian TGA Sponsor
Industry Category
Business Keywords
Company Description
MDSS is a leading business consulting and services provider, specializing in supporting In Vitro Diagnostic (IVD) and Medical Device (MD) manufacturers worldwide. Since 1994, MDSS has been committed to delivering comprehensive solutions that empower businesses to navigate complex regulatory landscapes and achieve their market access goals.
Located at Schiffgraben 41, Hannover, Lower Saxony 30175, DE, MDSS offers a range of essential services, including acting as an Authorized Representative (EC REP) and assisting with registration requirements across various member states. MDSS's expertise extends to vigilance and market surveillance, ensuring clients remain compliant and competitive. The company also provides Free Sales Certificates and support for new European CE marking regulations (MDR and IVDR), as well as current legislations (MDD, IVDD, AIMDD, and its national transpositions).
MDSS is certified to EN ISO 13485, demonstrating a commitment to quality and excellence. With additional offices at 6 Wilmslow Road, Manchester, M14 5TP, GB; Chicago, Illinois, 60630, US; Laurenzenvorstadt 61, Aarau, 5000, CH; and Suite 55, 377 Kent Street, Seabridge House, Sydney, NSW 2000, AU, MDSS provides global reach and localized support. We invite the management of MDSS to create a customized and exclusive company showcase and product listing on our platform to further enhance their market presence.
MDSS est un fournisseur leader de services et de conseils aux entreprises, spécialisé dans le soutien aux fabricants de dispositifs médicaux de diagnostic in vitro (DIV) et de dispositifs médicaux (DM) dans le monde entier. Depuis 1994, MDSS s'engage à fournir des solutions complètes qui permettent aux entreprises de naviguer dans des environnements réglementaires complexes et d'atteindre leurs objectifs d'accès au marché.
Située à Schiffgraben 41, Hannover, Lower Saxony 30175, DE, MDSS offre une gamme de services essentiels, notamment en agissant en tant que représentant agréé (EC REP) et en aidant aux exigences d'enregistrement dans divers États membres. L'expertise de MDSS s'étend à la vigilance et à la surveillance du marché, garantissant que les clients restent conformes et compétitifs. La société fournit également des certificats de vente libre et une assistance pour les nouvelles réglementations européennes de marquage CE (MDR et IVDR), ainsi que pour les législations actuelles (MDD, IVDD, AIMDD et ses transpositions nationales).
MDSS est certifié EN ISO 13485, ce qui témoigne d'un engagement envers la qualité et l'excellence. Avec des bureaux supplémentaires situés à 6 Wilmslow Road, Manchester, M14 5TP, GB ; Chicago, Illinois, 60630, États-Unis ; Laurenzenvorstadt 61, Aarau, 5000, CH ; et Suite 55, 377 Kent Street, Seabridge House, Sydney, NSW 2000, AU, MDSS offre une portée mondiale et un support localisé. Nous invitons la direction de MDSS à créer une vitrine d'entreprise et une liste de produits personnalisées et exclusives sur notre plateforme afin d'améliorer encore leur présence sur le marché.
Key Personnel / Employees
Compare Companies Side by Side
Compare MDSS with 3 companies in Business-Consulting-and-Services
| Comparison Field |
MDSSMain Company |
Johner Institut GmbHView Profile |
24hour-ARView Profile |
IMed Consultancy LtdView Profile |
|---|---|---|---|---|
|
Founded Year
|
— | 2005 | 2021 | 2012 |
|
Company Size
|
— | 51-200 | 2-10 | 11-50 |
|
City
|
Hannover, Lower Saxony | Konstanz, Baden-Württemberg | Bloxham, England | |
|
Country
|
Germany | Germany | ||
|
Skills & Keywords
Comparing with main company
|
30 Total Skills
Medical Device Regulations
IVDR Compliance
EC REP Services
Regulatory Affairs Consulting
Market Surveillance
CE Marking
ISO 13485 Certification
Active Implantable Medical Device
UK RP service
U.S Agent service
RoHS
EMC
France
Consulting
National Registrations (Italy
EC REP
Free Sales Certificates
GMDN & UMDNS Code
EC REP for Medical Devices & In Vitro Diagnostic Devices
Responsible Person (Cosmetics)
Australian TGA Sponsor
PPE
MDR
Spain
Portugal..)
LVD
IVDR
European Regulatory Affairs
UKCA
CH-REP
|
22 Total
22 Unique
Unique Skills:
510(k)
Audit
Clinical Evaluation
Clinical Investigation
Elearning
Electrical Safety
+16
|
27 Total
1 Common
26 Unique
Match
3%
Common Skills:
Market Surveillance
Unique Skills:
Autorised Representative (AR) Services
CE Mark
Consultancy
Consumer goods
Consumer Products
Declaration of Conformity
+20
|
19 Total
19 Unique
Unique Skills:
21 CFR Part 820
510k
Auditing
Clinical Evaluations
FDA
Global Registrations
+13
|
4
Total Companies2005
Oldest Founded1
Countries91
Unique SkillsSimilar Companies
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Alternative Company Names
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