Planbriq understands the critical importance of quality management (QM) and regulatory compliance to the success of your medical development projects. Our expertise in this area includes
QM strategy development: We support you in the development and implementation of a comprehensive QM strategy that is designed to achieve the highest quality standards while ensuring efficient work processes.
Audits and inspections: Our experienced audit and inspection experts provide comprehensive support for internal and external audits and regulatory inspections to ensure that your processes and facilities comply with applicable regulations.
GAP analysis: Our GAP analysis identifies the gaps between your current situation and your goals. We close these gaps with customized strategies to optimize your performance and maximize your success.
Risk management: We help you identify, evaluate and minimize risks by implementing solid risk management processes that ensure the safety and effectiveness of your products.
Regulatory compliance: With our in-depth understanding of regulatory requirements in the medical industry, we support you in the development and implementation of strategies for compliance with national and international regulations.
Document management: We offer efficient document management solutions to optimize the recording, review and management of documents as part of your quality and regulatory processes.
Conception and validation of serial processes: During this stage, we support you in transforming your prototype into a serial product - including all the necessary qualification processes, validation and documentation. As we already take user-orientated design, manufacturability, documentation, test specifications, packaging, logistics and maintainability into account during the prototype phase and conclude quality agreements with you, you will profit from a short time-to-market process during industrialization.
We are at your disposal to ensure that your products meet the highest quality and safety standards while complying with regulatory requirements.
Contact us today to learn more about how Planbriq can help you achieve your goals!