Developing medical technology products? Use this template to manage your medical device software design and engineering processes for compliance with EU MDR and US FDA regulations and applicable standards: IEC 82304-1, IEC 62304, ISO 14971, and FDA 21 CFR Parts 11 & 820.
Ensure high product quality and accelerate regulatory audits (ISO 13485, FDA 21CFR820) in the development of medical technology. Control quality documents, manage eForms and CAPA, and conduct Root Cause Analysis all in one place.
Support pharmaceutical project validation & Quality Risk Management in accordance with GAMP® 5 guidelines. Ensure high product quality, minimum waste, and compliance with regulations.
Minimize the use of resources, cut the costs of audit preparation, and tackle regulatory compliance (ISO 26262:2018, Automotive SPICE, CMMI, and other regulations) in the development of mobility technology.
Develop safe, reliable, and high-quality airborne products, aviation software, and embedded avionics systems. Implement mature processes, and efficiently report on the entire avionics development lifecycle to simplify compliance audits.
