Consulting service guiding U.S. medical device manufacturers through EU regulatory pathways, including CE certification under MDR, ISO 13485 quality management systems implementation, clinical evaluation, and technical documentation requirements.
Manufactured by
WQS Management Consultants Inc.
St. Petersburg, FL, United States
WQS Management Consultants GmbH Inc. is a globally recognized consulting firm that specializes in European MDR regulations and certification for medical devices with offices in Hamm, Germany and Florida, USA. We support life sciences companies worldwide in achieving successful market access to the European Union while managing compliance costs effectively. Our mission is to deliver cost-efficient, tailored regulatory solutions. We offer an extensive range of services, including: • CE Certification under EU MDR • Technical Documentation • Quality Management Systems (ISO 13485) • Regulatory Strategy and Market Access • Risk Management • Clinical Evaluation • Product Development Consulting • Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) • Remediation and Interim Regulatory Management • Audits and Notified Body Interaction for the Medical Device, Pharmaceutical (Combination Products), In-Vitro Diagnostics (IVD), Biotech and the Medicinal Laboratory Industry.
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