QMS (Medical Devices)
Medical device regulators in most markets require device companies to maintain a quality management system to obtain device approvals and registrations. Some markets recognize certification to international standards like ISO 13485; other markets require compliance with a local quality management regulation. Failure to comply with quality system requirements can be a hurdle for approvals and registration as well as jeopardize your standing with regulators post-market and disrupt product sales.
Maven’s quality management consultants bring loads of experience with medical device QMS development, implementation, and audits for all device risk levels. We can help you establish and maintain a quality management system that meets QMS requirements wherever your product is sold.
Achieve QMS compliance in medical device markets worldwide
We develop, implement, and maintain integrated quality management systems that comply with QMS regulations in all major medical device markets, including:
- United States
We also assist with gap analyses, due diligence, and internal, supplier, and preassessment audits. Our consultants guide you through every step of the process, including writing quality management system procedures, conducting and monitoring the implementation, and training your employees. We also assist in on-going compliance and maintenance of your QMS following implementation and certification (where applicable).
Risk and quality management in one integrated system
As the regulatory landscape evolves toward a lifecycle approach that emphasizes risk management, medical device companies must incorporate risk management processes throughout their business. Integrating risk management into your quality management systems is the optimal approach. If you already have an ISO 13485 or FDA QSR quality system, we can design and document a system for managing and evaluating risk that meets the requirements for ISO 14971.
We can help you implement a pre-production QMS
Maven has extensive expertise helping companies worldwide establish quality systems compliant with ISO 13485, FDA Quality System Regulation and other global QMS requirements. Our experienced consultants can establish procedures for regulatory compliance tailored to the specific markets you’re interested in entering.
As part of your QMS implementation, we will set up procedures for the following:
- Document and records control
- Training on regulatory requirements and internal procedures
- Design and development
- Risk management
- Software development (if applicable)
- Supplier evaluation
- Control of measurement of Product and Equipment
- Internal Audits & MRM
- Continual Improvement
- Data Analysis
- Post market activities (Complaints, Feedbacks, PMS, PMCF [if applicable])
We can also perform Third party internal quality system audits if you do not have the staff or resources to do so.
We understand that becoming conversant with CDSCO, European Regulations and US FDA Regulations can be very challenging.