Quality Systems Compliance
REU Associates knows that companies today have many challenges to manage a successful business. REU knows business and can help you develop a quality system that is both business-oriented and compliant with FDA and International Medical Device requirements.
Our quality systems compliance consulting services include:
• Gap Analysis of your business against US and international requirements for device manufacturing, distribution, and design.
• Quality System Implementations compliant with recognized quality management system standards (ISO 13485, ISO 9001) and regulations such as FDA's (QSR)Quality Systems Regulation, Canadian Medical Device Regulation(CMDR)and European Medical Device Directive (MDD).
• ISO Certification/CE Mark
Develop your business strategy to obtain ISO certification/CE Mark. These activities include:
- Notified Body selection
- ISO Certifier selection
- Authorized Representative selection
• Inspection Preparation / Preparedness
• Business Process Mapping
• Management Review Facilitation
• Management of your quality system processes, such as document control, corrective actions, internal audit, complaints
• Medical Device / Adverse Event Reporting Reviews
• Corrective Action Planning and Review
• Project Management
We use established project management methodology so that we can effectively manage your Quality System Implementation project, or lead your process improvement initiative.