ConformityinfoWhat are Clinical Evaluations and how they may affect your business?A Clinical Evaluation is an assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and…Sep 7, 2022Sep 7, 2022
ConformityinfoHow many procedures are too many or too few?When companies begin their quest for an ISO 9001 or ISO 13485 certification, they often wonder how many procedures do they need to satisfy…Aug 30, 2022Aug 30, 2022
ConformityinfoISO 9001Everyone has heard of the term, but do they truly understand what it means? Some people see it as an exercise in compiling paper and…Aug 10, 2022Aug 10, 2022
ConformityinfoQuality Management System: Understanding the OrganizationWhat defines and differentiates your organization? Is it a design house? Does it provide software development services? Does it manufacture…Aug 5, 2022Aug 5, 2022
ConformityinfoWhat is ISO 13485?Although the ISO 9001 Quality System standard can be used by any industry, ISO 13485 is the go-to Quality System standard widely used (and…Jul 26, 2022Jul 26, 2022
ConformityinfoQuality Management System: Employee RolesIf you are creating or in an organization, the question of what “role” each employee plays will come up. Naturally, we think of assigned…Jul 14, 2022Jul 14, 2022
ConformityinfoRisk ManagementThe topic of Risk Management often seems overwhelming. The reason for identifying risks is so that you can mitigate them and prevent bad…Jul 7, 2022Jul 7, 2022
ConformityinfoThe importance of documenting processesSuper employee Mitch has left the company! Will we ever be able to find someone to replace him? Probably not immediately. But if his work…Jun 27, 2022Jun 27, 2022
ConformityinfoQuality System Process ChangesContinuing with the Quality Management discussion that I started in my last blog, let’s talk about how changes may occur within a…Jun 9, 2022Jun 9, 2022
ConformityinfoMDD (Medical Device Directive) and Medical Device Regulation (MDR) Transitional ProvisionsIf you have CE marked products in Europe, you may already be aware of the change from the Medical Device Directive (MDD) to the Medical…May 26, 2022May 26, 2022
