Founded as a one-man business in 1993, WQS (at the time called “Wiatrek Qualitäts-Systeme” :-)) has grown into one of the leading consulting firms with deep expertise in regulatory approval, certification, and technical documentation of medical devices. Over the years, we have continuously expanded our services to meet evolving market demands.
We support companies with everything from micro-consulting for specific regulatory questions to fully outsourced regulatory management. Our all-in-one regulatory service even extends to „CE hosting,“ where we take on the legal manufacturer role while our clients retain full product rights.
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.
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.
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.
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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