Take your Step into the European Medical Device Market
With over 30 years of experience in the Medical Device Industry,
we support you with all the essential Steps to enter the European Market
Medical Device Approval MDR
WQS specializes in CE certification for medical devices, international approvals, and services in the field of medical technology.
FDA Approval (510(k), PMA)
The approval of medical devices in the USA is regulated by the Food and Drug Administration (FDA) and is based on the Federal Food, Drug, and Cosmetic Act (FDC Act).
International Registration
Our global network of experienced partners and regulatory experts ensures that your products efficiently meet the specific requirements of each country.
Consulting on MDR approval and Certification for Medical Devices
We guide you safely through all the requirements for successful approval and certification of your medical devices.
Medical Devices Consulting
Our services for you
CE Certification
for 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.
Technical Documentation
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.
Risk Management record for Medical Devices
The Risk Management System for Medical Devices in accordance with EN 14971 is an indispensable element for Medtech Companies.
Quality Management
System
Quality Management is essential in the manufacture of medical and dental devices, covering all employees and processes for compliance and certification.
General Safety & Performance Requirements (GSPR)
Manufacturers must appoint a qualified “Person Responsible for Regulatory Compliance” (PRRC) and register them in Eudamed.
Clinical Evaluation of Medical Devices
Clinical Evaluation and Studiesare regulated by Medical Device Law. We support compliance with MDR requirements to ensure safety and performance of your Devices.
Monitoring the PMS and PMCF markets
The responsibility extends beyond sale. Post-Market Surveillance, Market Monitoring, and Post-Market Clinical Follow-Up are essential to ensure ongoing patient safety.
Cleaning Validation of Medical Devices
To bring Medical Devices into the market in a hygienically compliant state, all critical impurities must be minimized and acceptance criteria met.
Software Validation of Medical Apps
There are three systems for validating Medical Software and Apps. We assist with the certification and validation process for Medical Devices and Apps.
In-Vitro Diagnostics (IVD)
In-Vitro Diagnostic Medical Devices are classified into groups to determine applicable conformity assessment procedures.
Pictograms for Medical Devices
Here you’ll find common Symbols and Pictograms used on labels, packaging, and devices, aligned with EU requirements.
Medical Device Consultant Training
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.
Glossary
A Medical Device is an instrument, a device, an equipment or software that is used for medical, therapeutic or diagnostic purposes for humans.
Medical Devices & Pharmaceuticals
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.
Risk Classification
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.
EN ISO 13485 for Medical 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.
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Regulatory Affairs Consulting for Medical Devices Since 1993, Certified According to ISO 13485
WQS Management Consultants consults manufacturers of medical devices and in vitro diagnostic devices on their path to market access in Europe and the U.S.
Our own quality management system is certified by TÜV NORD Polska to ISO 13485. The certification covers consulting on quality management and regulatory affairs, as well as the storage and packaging of medical devices on behalf of clients.
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Regulatory & Quality • WQS
Take your Step into the European Medical Device Market
Regulatory requirements determine market access. We assess your situation and determine the next steps.
Frequently Asked Questions on Medical Device Regulation
What does WQS do?
WQS Management Consultants advises medical device and IVD manufacturers on regulatory affairs and quality management. FDA, QMSR, ISO 13485, MDR and IVDR. Since 1993, with offices in the United States and Germany.
What does WQS handle for the US market?
WQS supports manufacturers with FDA requirements, US Agent representation and the Technical File from an office in St. Petersburg, Florida. The focus is on concrete evidence, not general recommendations.
What is required for CE marking in the EU?
CE marking requires a full conformity assessment under MDR or IVDR – from classification through technical documentation to the Declaration of Conformity. For US manufacturers, an EU Representative is mandatory.
What belongs in the technical documentation under MDR?
The technical documentation requires GSPR evidence with product-specific test reports, a clinical evaluation, traceable UDI references and a documented post-market surveillance system.
What does the regulation require for risk management?
Risk management under EN ISO 14971 must be demonstrated across the entire product lifecycle as an ongoing process linked to clinical evaluation and post-market surveillance.
When is an ISO 13485 quality management system required?
For most medical device manufacturers, an ISO 13485 QMS is a precondition for conformity assessment. It covers CAPA processes, document control and audit preparation for Notified Bodies. Under FDA QMSR, ISO 13485 now aligns closely with US requirements.
What does the Notified Body check in the clinical evaluation?
The clinical evaluation must address the specific product, not the device class. A missing product link is a common reason for deficiency letters.
Which laboratory tests are relevant for medical devices?
Depending on the product, evidence on packaging, aging or biocompatibility is required as part of the technical documentation. WQS coordinates the appropriate laboratory tests and assesses the results from a regulatory perspective.
Does WQS have a presence in Europe?
Yes. WQS was founded in Germany in 1993 and operates from Hamm, North Rhine-Westphalia. That is where the EU regulatory expertise for MDR and IVDR sits.
