Quality and Compliance
Moellers Operational Excellence provides QMS project support (ISO13485), ranging from updates and improvements for individual procedures and work instructions, to implementing new eQMS solutions. This includes solutions for spin-outs through to global franchise integration and harmonization across multiple production sites.
Risk Management: We help your organization to identify, assess and mitigate risk throughput the product lifecycle. ISO 13485 sets the standard for quality management systems, emphasizing regulatory compliance, patient safety, and risk-based decision-making. Our team members assist you in implementing robust risk management processes, ensuring that risks related to product design, development, production, and post-market activities are systematically controlled, reducing the likelihood of failures and enhancing product quality and safety. This approach supports both regulatory approval and long-term business success.
Data integrity: Data integrity and compliance ensure the accuracy and reliability of information throughout the medical device lifecycle. This involves strict controls over data management and validation to meet regulatory standards, support patient safety, and uphold product quality. We help you to establish robust data practices preventing errors and ensuring decisions are based on reliable information, essential for regulatory adherence and quality assurance.
We can deliver a consulting focussed on one or several areas of your Quality Management System; from Design Control to Post Market, including complaints and CAPA processes.