We guide you through EU Registration: CE Certification, Classification, Clinical Evaluation and Notified Body involvement.
We act as your authorized EU Representative: we ensure regulatory compliance, act as your interface to authorities and maintain your product documentation in the EU.
We provide compliant storage and EU-based labeling, dispatching and shipping for your sterile or regulated devices.
We manage your EUDAMED registration and guide you through obtaining a Single Registration Number (SRN).
You’re ready to sell in the EU!
We remain at your side to ensure long-term compliance through Post-Market Surveillance.
Take your step into the European Market. With over 30 years of experience in the Medical Device Industry, we support you with the following services:
Supporting compliance for a wide range of Medical Device Categories, including: Dental products, Implants, Active electrical medical devices, Surgical instruments, Diagnostic equipment, Single-use medical products & Hospital and homecare devices
Let us guide you through the Medical Device Requirements for a successful entry into the European Market.
A Medical Device is an instrument, a device, an equipment or software that is used for medical, therapeutic or diagnostic purposes for humans.
The longer and deeper a device is used in the body, the higher its risk class (I, IIa, IIb, III) – based on its intended purpose under EU regulations.
Quality Management is essential in the manufacture of medical and dental devices, covering all employees and processes for compliance and certification.
Here you’ll find common Symbols and Pictograms used on labels, packaging, and devices – aligned with EU requirements.
Over 30 years of quality and experience.
Your competent partner for Technical Documentation,
Clinical Evaluation and Quality Management of Medical Devices.
CE certification is mandatory for Medical Devices in the EU. It confirms that the product meets all applicable safety and performance requirements under European regulations.
The Risk Management System for Medical Devices in accordance with EN 14971 is an indispensable element for Medtech Companies.
Meeting the General Safety & Performance Requirements. Manufacturers must appoint a qualified “Responsible Person” and register them in Eudamed.
The responsibility extends beyond sale. Post-Market Surveillance, Market Monitoring, and Post-Market Clinical Follow-Up are essential to ensure ongoing patient safety.
Technical Documentation is required for all Medical Devices, regardless of Class (I, IIa, IIb, III). Compliance with MDR includes the Device Master File for all Device Classes.
Clinical Evaluation and Studiesare regulated by Medical Device Law. We support compliance with MDR requirements to ensure safety and performance of your Devices.
Manufacturers must establish and maintain a Quality Management System under ISO 13485 for Medical Devices in the EU market. We ensure compliance and certification.
While not mentioned in the MDR, the Medical Device Advisor is required in Germany. Manufacturers must appoint and train their MPBs. We offer Medical Device Consultant Training under § 83, with online courses and expert guidance..
There are three systems for validating Medical Software and Apps. We assist with the certification and validation process for Medical Devices and Apps.
To bring Medical Devices into the market in a hygienically compliant state, all critical impurities must be minimized and acceptance criteria met.
The distinction between Medical Devices and Pharmaceuticals can be complex. Differentiation is based on their intended primary effect, with classification depending on this key factor.
In-Vitro Diagnostic Medical Devices are classified into groups to determine applicable conformity assessment procedures.
Support for US companies to enter the European market. EU Rep, Certification, QM System, Technical Documentation, support of the Procedure, selection of a Notified Body, support of the Certification Procedure, preparation of a Clinical Evaluation, support of Clinical Studies, including the Logistical Concepts.
WQS Management Consultants Inc
136 4th Street north, Suite 201
St Petersburg, Florida 33701
Telefon: (925) 212-7683
Email: werner@us.wqs.de
Web: us.wqs.de
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