Manfred MaiersRegulatory Compliance: Just the Entry Ticket to the World of Medical DevicesIn the medical device industry, regulatory compliance is often viewed as the primary hurdle a company must overcome to launch a product in…Sep 20Sep 20
Manfred MaiersThorough Due Diligence: An Essential Tool in Mergers and AcquisitionsIntroductionAug 4Aug 4
Manfred MaiersNo Deployments on Fridays: A Good Practice for Manufacturing and Software DevelopmentI was reading an insightful article on Medium about the “CrowdStrike” security incident that disrupted the lives of millions of people on…Jul 20Jul 20
Manfred MaiersProduct Recalls in MedTechThe medical device industry has encountered significant challenges in the first half of 2024, marked by a total of 756 product recalls…Jul 17Jul 17
Manfred MaiersAI: The Mother of All Disruptive InnovationsIntroduction to Disruptive InnovationJun 25Jun 25
Manfred MaiersThese are not the KPIs you are looking forCAPA KPIs: Enhancing Your Quality Management ProcessJun 241Jun 241
Manfred MaiersUnderstanding Lead and Lag Indicators in Medical Device ManufacturingIf you are a medical device manufacturer and have implemented production and process controls as required by ISO 13485 and FDA 21 CFR part…Jun 201Jun 201