WQS Management Consultants Inc. was founded in 2025 in St. Petersburg, Florida, and has over 30 years of experience in regulatory approval, certification, and technical documentation for medical devices.
We help U.S. manufacturers navigate FDA requirements and enter the EU market under MDR and IVDR. With our own ISO 13485-certified we cover storage and fulfillment requirements for manufacturers preparing EU market entry. Our team combines direct U.S. market experience with the regulatory depth that comes from decades in the European medical device sector.
Founded in St. Petersburg, FL
Years of regulatory expertise behind us
Certification projects completed across both entities
510(k) & PMA Clearance
under the FDA
QMSR / 21 CFR Part 820
FDA’s QMSR
U.S. Agent Service
FDA Representation
CE Marking
under MDR 2017/745
EU Authorized Representative
under Article 11 MDR
Technical Documentation
under Annex II and III
Risk Management
under EN ISO 14971 MDR
ISO 13485-Certified Warehouse
Storage and fulfillment
International Certification
Targeted advisory on regulatory topics
WQS Management Consultants GmbH was founded in 1993 in Hamm, Germany, initially as a one-person consultancy under the name Wiatrek Qualitäts-Systeme. Over three decades it grew into one of Germany’s established regulatory affairs consultancies for medical device manufacturers, with a team of 20 specialists and ISO 13485 certification.
The 250+ certification and CE marking projects completed by WQS span device classes I through III, IVDs, implants, active electrical devices, surgical instruments, combination products, and diagnostic systems from SMEs to global pharmaceutical groups.
WQS Inc. is not a standalone startup. It is the U.S. entity of that organization with access to the same regulatory depth, the same documentation standards, and the same direct experience with EU Notified Bodies that WQS Germany has built since 1993.
Our success is built on the expertise and dedication of our employees. A team of 20 professionals collaborates to ensure compliance and innovation in the medical device industry. Bachelor’s and master’s students further strengthen our expertise by contributing to research and scientific projects.
We value flexibility, continuous training opportunities, fair compensation, and a strong team spirit.
Become part of our team! We offer a diverse and interesting range of roles in a medium-sized engineering company in Hamm (Westphalia) with long-term, structure-building, and impact-oriented projects.
For more information on current job openings, working student positions, and thesis projects, please visit our careers page:
With over 250 successful certification and CE marking projects, we have helped SMEs, micro-enterprises, and global pharmaceutical companies bring their medical devices – including injectors, combination products, and more – to the European market.
Throughout our 30-year history, we have completed numerous successful regulatory and certification projects. Here are some examples of key projects we have handled:
| Industry | Category | Products | Medical Decice Class, Risk Class | Project |
|---|---|---|---|---|
| Corporate Brand | approx. 800 employees | Ear thermometers, Blood pressure monitors, Thermometers | Im | Maintenance of Technical Documentation, Support in switching the notified body |
| International Group, Subdivision | > 20.000 | Silicones for medicine | I and IIb | Development of a clean room production, Coordination of the certification process, Testing concept |
| International Pharmaceutical Manufacturer, Subdivision | >20.000 | e.g. Automatic Syringe Machines, Medication Application | IIb | Supplier Qualification, Supplier Audits, FDA Approval, Dossier Creation for Medical Devices, Partial Certification ISO 13485 and Annex II of Directive 93/42/EEC |
| Software Company | approx. 25 employees | Software Development, Databases, HL7, DICOM | IIa | Clinical Evaluation, Risk Management, Introduction of DIN EN 62366 and EN ISO 62304 Usability and Software Life Cycle |
| Producer | approx. 100 employees | Development, Production and Distribution of Medical Embrocations, Heating Pads and Medical Gels | I | EN ISO 13485 introduced, SOP for the creation of Product Files/Technical Documentation, Training of Employees, Training of the Safety Officer for Medical Devices |
| OEM Manufacturer | approx. 100 employees | Incontinence Aids | IIa | EN ISO 13485, Application for an Aid Number |
| Pharmaceutical Manufacturer | approx. 100 employees | Oxygen Therapy | IIb | EN ISO 13485, Integration of ISO 13485 into the existing GMP System |
| Retail Chain | approx. 350 employees | Hearing Aids, Hearing Devices, Hearing Protection | IIa | EN ISO 13485, DIN EN ISO 14971 |
| Engineering Office | 3 employees | Special Hearing Aids | Custom-made Devices | Inclusion in the List of Aids |
| Pharmaceutical Manufacturer | approx. 150 employees | Wound Irrigation Solutions, Medical Devices Borderline, Contract Manufacturer | IIa und IIb | Performance of Supplier Audits, Implementation of ISO 13485 into the existing GMP system, Full Service for the approval according to Appendix II |
| Generic Manufacturer | > 1.000 | Medical Borderline Products, Sterile Administration | IIa und IIb | Training of the Development Department (Galenics) in the field of Medical Devices, Collaboration in the Technical Documentation, Preparation of the Clinical Evaluation according to MEDDEV 2.7.1 |
| Corporate Group | > 1.000 | Alloys, Resorbable Bone Replacement Material | III und IIA | Feasibility Analysis, Classification Analysis, Communication with BfArM, Clinical Evaluation |
| Pharmaceutical Trading Company | approx. 50 employees | Intestinal Health | IIb | Preparation of the Clinical Evaluation according to MEDDEV 2.7.1 |
| Trader | approx. 8 employees | Hyarolunate | III | Implementation of the OEM Procedure, Certification according to Appendix II.3 |
| Producer | approx. 15 employees | Production of Physiotherapeutic Products | I | Preparation of the Clinical Evaluation according to MEDDEV 2.7.1 |
| Manufacturer | 8 employees | Manufacturer of Sterile Class IIA Products, Endoscopy | IIa | DIN EN ISO 14971 |
| OEM Manufacturer | approx. 150 employees | Medical Disposables, Sterile and Non-Sterile, Consumables | I s, 1 | Implementation of the OEM Procedure, Delimitation Contract, Inspection Concept for Incoming Goods developed |
| Trader | 3 employees | Medical Specialties for Intestinal Rehabilitation | IIa | Preparation of the Clinical Evaluation according to MEDDEV 2.7. |
| Trading Company | 10 employees | Medical Devices Class 1, Home Shopping | 1 | TD Creation, Training of Medical Device Consultants, Delimitation issues with regard to the Therapeutic Products Advertising Act |
| Trading Company | 5 employees | Light Therapy Devices, Electrostimulation | 2a | Implementation of the PLM Procedure, Preparation for the Certification Audit |
| Pharmaceutical Manufacturer | 15 employees | Borderline Medical Devices, Sterile Administration | 1s II a | Creation of a responsibility delimitation Policy, Training of employees, Creation of SOP’s in the area of Medical Devices |
| Direct Sales Austria | approx. 25 employees | Borderline Medical Devices, Food Supplements, Medicinal Products | IIa | Preparation of the Clinical Evaluation according to MEDDEV 2.7.1 |
| Single Enterprise | 1 employees | Medical Lubricants, Protection against sexually transmitted Diseases | I | Obtaining CE Marking for Class 1 Products, Registration with the Authorities, DIN EN ISO 14971 |
| Electrical Engineering Office | > 10 employees | CE Mark for Medical Software against Fraud | IIa | Workshop Risk Management, Introduction of DIN EN ISO 62366 and DIN EN ISO 62304, Usability and Software Life Cycle, Software Architecture |
| Trading Company OEM PLM | < 10 employees | Suture Material, Implants, Holders | IIb | Creation of responsibility delimitation Contracts, OEM/PLM Procedures, Appendix II Certification |
| Production Company | < 10 employees | Cryotherapy Devices, Skin | II a | Organization of the Production Area with regard to the Manufacture of Medical Devices |
| Brand Manufacturer | > 150 employees | Cooling Pens, Bleaching Agents, Skin Therapeutics | IIa und IIb | Creation of responsibility delimitation Contracts with OEM Manufacturers, Supplier Audits, Collaboration on Product Files |
| Manufacturer, Distributor, Developer | >10 employees | Dental Implants, Bioactive Surfaces | IIb und III | Collaboration on Technical Documentation |
| Production | > 10 employees | Cold Therapy, Plasma | IIa | Preparation of the Clinical Evaluation according to MEDDEV 2.7.1 |
| Trade | < 5 employees | Dental Trading Company | I-IIb | DIN EN ISO 14971 |
| Distribution | < 25 employees | Cardiac Catheter Measuring Station, Diagnostic Software | IIb, III | Risk Management, Introduction of Standard EN 62366 and DIN EN ISO 62304 Usability and Software Life Cycle, Implementation of EN 60601 – ff |
| Producer, Trading Company | approx. 160 employees | Manufacturer of Tablets, Food Supplements, Medical Devices | IIa | Preparation of Clinical Evaluation according to MEDDEV 2.7.1 |
| Brand Company | approx. 500 employees | Sterile Disposables, Urology, Diagnostics IVD | IIa, I S | Validation of Sterilization, In Vitro Diagnostics Specificity, CE Marking Medical Device especially IVD |
| Trading Company | approx. 20 employees | Orthodontic Consumables | IIa, 1 | Implementation of the entire Certification Procedure |
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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