FDA – Digital Health Software Precertification (Pre-Cert) Program

The Software Precertification (Pre-Cert) Pilot Program, as outlined in the FDA's Digital Health Innovation Action Plan [PDF], will help inform the development of a future regulatory model that will provide more streamlined ...

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MedSysCon Medizintechnik GmbH

MedSysCon offers consulting services in Medical Engineering providing tailor-made scalable solutions for international quality and regulatory compliance. We are providing comprehensive services covering the overall product lifecycle from the idea to the approved product.

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FDA launches Digital Health Center of Excellence

The FDA has launched its Digital Health Center of Excellence (DHCoE), as the agency continues with its commitment to advancing use of technology such as mobile health devices, software and wearables to create medical products. The FDA announced: “The launch of the Digital Health Center of Excellence ...

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Is Computer Software Assurance (CSA) the new CSV?

The FDA draft guidance on Computer Software Assurance is a paradigm shift from document focused computer system validation to critical thinking assurance practices. The Guidance is on FDA’s list for release in September 2020 and applies to non-product quality system software solutions. The principles ...

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DevOps – A Culture of Shared Responsibility

DevOps combines the development and operations activities of an IT organization to increase collaboration and automation along the entire product lifecycle. Specifically, the approach breaks down the walls within IT to embed employees from IT operations onto cross-functional agile teams ...

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FDA’s Transition From Computer System Validation To Computer Software Assurance

FDA is preparing to release new guidance, Computer Software Assurance for Manufacturing, Operations and Quality Systems Software, in late 2020. This new guidance will provide guidelines for streamlining documentation with an emphasis on critical thinking, risk management, ...

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MDCG 2019-16 – Guidance on cybersecurity for medical devices

MD101 comments in their recent blog the new guidance on cybersecurity for medical devices: the MDCG 2019-16: “This guidance covers a broad range of topics applicable to all stakeholders in the medical device supply chains, and to end-users. It explains a bit why ...

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EUDAMED: Four Modules Due To Come Online By Mid-2021

The medtech sector is getting impatient with the European Commission’s frequent changes in the launch date for the new Eudamed medical device database, a foundation stone for the new regulations. The commission has just announced an ambitious new timetable. MEDTECHDIVE reports that The Commission ...

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Cybersecurity Vulnerabilities in Healthcare

The issue with medical technology is the cybersecurity isn't up to the level of where it needs to be, and criminals know this. Manufacturers that build these products have a treasure trove of sensitive information on vendors and clients alike. If medical device makers don't perform their due diligence by conducting a criminal ...

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Healthcare: Confidence in Cloud Computing grows

healthcare-in-europe.com comments on Johan Sjöberg, a medical physicist at Karolinska University Hospital in Stockholm, Sweden, who claims that cloud computing in healthcare is a couple of decades behind the rest of society. “The purpose of a well-functioning healthcare system is to provide excellent care to its patients ...

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FDA issues Digital Health Innovation Action Plan

From mobile medical apps and software that support the clinical decisions doctors make every day to artificial intelligence and machine learning, digital technology has been driving a revolution in health care. Digital health tools have the vast potential to improve our ability to accurately diagnose and treat disease ...

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EU permits remote notified body audits during pandemic

Medtechdive.com reports that the European Commission's Medical Device Coordination Group (MDCG) is allowing notified bodies to perform remote audits during the coronavirus outbreak, according to a guidance posted Wednesday. The MDCG detailed how notified bodies can run audits while quarantine orders ...

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FDA proposed Regulatory Framework for Al/ML- Software as a Medical Device

On April 2, 2019, the FDA published a discussion paper “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) - Discussion Paper and Request for Feedback” that describes ...

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EU plans to postpone the MDR by one year

According the EU spokesperson for public health and food safety, Stefan de Keersmaecker, the EU commission is working on a proposal to postpone the EU MDR by one year. This is mainly due to Covid-19 and should release the pressure on governments and manufacturers so they can focus on this crisis.

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FDA okays Roche’s COVID-19 diagnostic test

PMLIVE reported in its pharma news that the US Food and Drug Administration (FDA) has approved Roche’s diagnostic test for the novel coronavirus, authorising it for emergency use. The cobas SARS-CoV-2 test is intended for qualitative detection of the novel coronavirus (SARS-CoV-2), which causes the respiratory disease COVID-19. Nasopharyngeal and oropharyngeal swab samples are taken from patients who have symptoms consistent with COVID-19, with these sample ...

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FDA postpones foreign medical device inspections due to COVID-19 concerns

The U.S. Food and Drug Administration is postponing inspections outside of the U.S. in response to the COVID-19 outbreak. The FDA is postponing most foreign inspections through April 2020, effective immediately. Inspections outside the U.S. deemed mission-critical will still be considered on a case-by-case basis. For medical device manufacturers based outside the US which are dependent on FDA inspections to obtain …

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Don’t Let Data Integrity Be Your Achilles’ Heel

MasterControl recently published an article by Gina Guido-Redden showing that the FDA has been actively defining detailed expectations for data integrity since 1997 when they supplemented 21 CFR Part 211’s predicate rules on records and record keeping, by publishing Title 21’s first set of regulations directly defining the rules for electronic records and electronic signatures (21 CFR part 11). However, more than a decade passed …

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FDA recognizes ISO 14971:2019 as consensus standard

On Jan 14, 2020 the US FDA has granted Recognized Consensus Standard status to the third edition of the ISO 14971 risk management standard for medical devices and IVD. The transition period of the previous standard edition, ISO 1497:2007, will last through late 2022. Therefore, any declarations of conformity to ISO 14971:2007 included in medical device and IVD premarket submissions will be accepted by the FDA until December 25, 2022.

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Major conglomerates bet on healthcare

Medtechdive.com reports about major global conglomerates like 3M and Philips have taken steps to increase focus on healthcare in recent years, shedding units covering other industries while buying additional medical assets in the belief the aging population will drive growth. GE took a different path, initially planning to spin off its healthcare unit (like Siemens did with a 2018 Healthineers IPO), only to decide to keep it in the fold.

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Security for Connected Medical Devices

Medical Product Outsourcing Magazine (MPO) reports on security measures for Connected Medical Devices. Every day, medical device manufacturers throughout the world race to develop new, highly sophisticated and increasingly connected products. These products offer a wide range of benefits: improved treatments, more precise diagnostics, better patient monitoring, automated control and central reporting, and monitoring of data. However, ….

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Software as a Medical Device (SaMD)

Orthogonal.io reports about the emerging trend within the medical device industry: Software as a Medical Device (SaMD). Over the last 40 years, the amount of software used both in and around medical devices has dramatically increased. The last 20 years in particular have seen an acceleration in this trend, thanks to the emergence of the “internet of things” (IoT) and its corresponding parts — smartphones, wireless connectivity, cheaper and …

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Take Control of your Business – Digitize it!

Your Challenge As a manufacturing manager in the pharmaceutical or medical device industry you are sometimes confronted with fragmented, inconsistent and inaccessible manufacturing operations data – often distributed across paper, spreadsheets, various computer applications, databases and measuring systems. The missing link between multiple legacy systems often causes a lack of manufacturing control and end-to-end visibility.

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