With over 30 years of experience in the Medical Device Industry,
we support you with all the essential Steps to enter the European Market
WQS specializes in CE certification for medical devices, international approvals, and services in the field of medical technology.
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).
Our global network of experienced partners and regulatory experts ensures that your products efficiently meet the specific requirements of each country.
We guide you safely through all the requirements for successful approval and certification of your 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 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.
The Risk Management System for Medical Devices in accordance with EN 14971 is an indispensable element for Medtech Companies.
Quality Management is essential in the manufacture of medical and dental devices, covering all employees and processes for compliance and certification.
Manufacturers must appoint a qualified “Person Responsible for Regulatory Compliance” (PRRC) and register them in Eudamed.
Clinical Evaluation and Studiesare regulated by Medical Device Law. We support compliance with MDR requirements to ensure safety and performance of your Devices.
The responsibility extends beyond sale. Post-Market Surveillance, Market Monitoring, and Post-Market Clinical Follow-Up are essential to ensure ongoing patient safety.
To bring Medical Devices into the market in a hygienically compliant state, all critical impurities must be minimized and acceptance criteria met.
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 Diagnostic Medical Devices are classified into groups to determine applicable conformity assessment procedures.
Here you’ll find common Symbols and Pictograms used on labels, packaging, and devices, aligned with EU requirements.
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.
A Medical Device is an instrument, a device, an equipment or software that is used for medical, therapeutic or diagnostic purposes for humans.
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.
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.
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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Over 30 years of quality and experience.
Your competent partner for Technical Documentation,
Clinical Evaluation and Quality Management of Medical Devices.
Regulatory requirements determine market access. We assess your situation and determine the next steps.
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.
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.
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.
The technical documentation requires GSPR evidence with product-specific test reports, a clinical evaluation, traceable UDI references and a documented post-market surveillance system.
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.
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.
The clinical evaluation must address the specific product, not the device class. A missing product link is a common reason for deficiency letters.
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.
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.
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.
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This page provides regulatory information and does not constitute legal advice. Regulatory requirements vary by jurisdiction.
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