Regemon is a consulting and training firm assisting medical device companies in the area of quality, regulatory compliance and clinical services.
Enjoy the benefits of external regulatory and compliance support to provide a specific expertise or to manage workload during personnel shortages or high workload situations.
Regemon provides support throughout product lifecycle: from concept/ feasibility and product design/ development through post-market compliance. Our short- and long-term strategies ensure an efficient product development program and timely product approvals.
Our services are focused on assisting small and mid-size companies achieve regulatory compliance with FDA, European Union, Health Canada, Australian and Japanese regulations:
- Implementing compliant systems and processes (FDA QSR, CE Marking under Regulation (EU) 2017/745 (referred to as EU MDR), Health Canada MDR and Japanese PAL.
- Obtaining Pre-market approvals (510(k), EU Technical Documentation files in accordance with EU MDR Annex II & Annex III (alias Technical Files or Design Dossiers under the MDD).
- Staying in compliance (audits, training, FDA and Vigilance reporting).
- Resolving regulatory problems (Crisis Management) – FDA audit response (483), warning letters, Notifed Body certificate suspenssions, and product recalls.
We provide practical solutions and work with you to develop and implement effective regulatory strategies, prepare domestic and international regulatory submissions, manage FDA and foreign regulatory agencies inspections and train your employees in all aspects of regulatory compliance.
Offices in: USA (San Antonio, Texas) and Europe (Hamburg, Germany)