For highly regulated industries like life sciences and pharma, industry-specific quality management systems (QMS) address the complex product development lifecycle of pharmaceutical, biotech, and medical devices products. Medical QMS—also referred to as medical device QMS or QMS for life sciences—is designed to facilitate compliance with regulations enacted by the FDA and standards like ISO 13485 (the International Organization for Standardization specific to medical devices). Additionally, with a medical QMS, life science businesses can eliminate paper-based quality processes, improve product quality and safety, reduce overall costs, increase operational efficiency, and unify and standardize processes, documentation, and communication.
If you are looking for a quality system that facilitates the standardization and maintenance of standard operating procedures (SOP) or internal business processes, take a look at the healthcare compliance software. Additionally, some horizontal quality management software solutions can be, and are, used for less complicated quality processes for pharmaceutical, biotech, and medical device products.
To qualify for inclusion in the Medical QMS category, a product must:
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Greenlight Guru is the only quality management platform designed specifically for medical device companies. The platform helps companies get safer products to market faster, simplifies FDA and ISO regulatory compliance and provides a single source of truth by connecting the management of all quality processes like CAPAs, risk, audits, document control, training, design control and more. Device makers across the globe are replacing their outdated paper-based and general purpose legacy quality
Qualio is modern quality management software (QMS) that unites your team, tools, and data. Designed for life sciences companies (medical device, pharma, biotech, and contract organizations) who develop, produce and distribute life-saving products and services. Crush Audits Always be audit-ready with full visibility and control over what's happening anywhere in your system. Quickly identify issues and close gaps to ensure activities are scheduled and completed on time. Eliminate Defects Identif
Quality & Project Management for achieving and maintaining ISO 13485:2016, CE Mark or U.S.QSR (21CFR 820) for 510(K) Compliance Success. qmsWrapper integrates 5 separate software into 1 complete cloud based system, including Project, Risk, Document and Quality Management modules with built-in Team Messaging for the best Collaborative Compliance experience. Quality managers with little experience can easily step into the role and effectively start. Create safer, better, medical devices and
Ennov Doc is part of Ennov's ECM platform for regulated industries, especially the Life Sciences Sector. Our solution is recognized by Gartner as a relevant actor in the Life Sciences sector (mentioned in Gartner's Hype Cycle for Life Sciences Reports as a Regulated SaaS EDMS, as well as for eTMF and QMS) , and suitable for large as well as small organizations. It comprises in the same interface and completely integrated : Document management (EDMS), Business process management (BPMS), Dossier
Ennov Process allows you to automate your Quality processes and enforce the activities, participants and traceability required by your SOPs using our visual form builder and graphical workflow modeling utilities. Ad hoc processes or those that remain stalled for months are a thing of the past.
Cloud-based Electronic Device History Record software with integrated modules that manage documents, inventory, and quality assurance together with the device history records. The software will guide you through the workflows required for manufacturing medical device Class II and Class III products.