FDA Releases Guidance On Cybersecurity In Medical Devices

The digital revolution that resulted in the Internet of Things (IoT), Internet of Medical Things (IoMT), Software as a Medical Device (SaMD), and connected devices permeating the healthcare environment, both in the hospital ...

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Key Design Considerations For Digitally Connected Injectors

Digital health has become an integral part of clinical trials and the commercial patient support ecosystem. In the past two years, there has been a significant transformation in the way clinical trials are conducted, as well as how healthcare providers support patients ...

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Medical Device Interoperability

Medical device interoperability is the ability to safely, securely, and effectively exchange and use information among one or more devices, products, technologies, or systems. This exchanged information can be used in a variety of ways including display, ...

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How To Update my QMS for FDA QMSR Amendment Compliance?

Now that the FDA has officially announced its intention to harmonize and modernize 21 CFR Part 820 Quality Management System Regulation (QMSR) for medical devices, the question is: What do I need to do to my quality management system (QMS)? If your QMS is based on ...

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FDA Releases Guidance On Digital Health Data Acquisition In Clinical Investigations

Increasingly, digital health technologies (DHT) are becoming part of the conduct of clinical trials for pharmaceuticals and medical devices. They cover an extremely broad range of applications, including ingestible ...

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Nine Pitfalls To Avoid In Data Integrity

Part 11 compliance has been around for about 20 years,1 but still today I see confusion in the industry. While most elements have been implemented successfully, in part attributable to the array of great software available in the marketplace, there are still areas ...

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Advancing Patient Care With Wearable Medical Devices

While wearable medical devices1 offer the opportunity to monitor, diagnose, and deliver individualized care to patients, adoption by clinicians has yet to gain significant traction. However, the COVID-19 pandemic has raised awareness of wearables ...

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MedSysCon – The faster way to medical device compliance

The regulatory and quality landscape for medical devices is constantly evolving. The mission of MedSysCon is to deliver specialized consultancy services for regulatory affairs and quality assurance, focused on the digital health industry. Our content and solution driven, ...

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Make Your Medical Device Start-Up More Investable

A particularly tough challenge for medical device start-ups is that the executives tend to be the scientists and inventors of the device. When it comes to funding, you need to trade your inventor hats for business ones and learn to think like an investor. It’s not an easy task, ...

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Meet Hearables – The Next Revolutionary Medical Devices

Hearables, in-ear devices that use sensors to monitor health, are on the brink of becoming the next revolutionary technology. While in-ear devices have been around for decades in various iterations (used primarily for transmitting sound), the application of this technology ...

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Wearable Cardiac Monitoring

Cardiac monitoring is almost a standard feature of modern wearables but there are still opportunities to get better information and do more with the data. Seizing those opportunities could transform everything from medical care to athletic training and general well-being. Cardiac monitoring has been around for over 100 years, ...

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FDA’s Upcoming Computer Software Assurance Guidance

The medical device industry can benefit greatly by implementing CSA. In a recent European study1 on medical devices, AI application categories and types were researched and cited as producing data that can be collected and analyzed throughout the life cycle of the patient...

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DevOps: What It Is and Why It Matters

Though there are no surefire, “silver bullet” methods for improving IT efficiency, DevOps has yielded results that are hard to ignore. As its name suggests, DevOps combines software development and software operations principles with the goal of helping organizations ...

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UK seeks overhaul of AI, software as a medical device regs

The U.K.'s Medicines and Healthcare products Regulatory Agency is overhauling its regulations applying to software and artificial intelligence as a medical device. MHRA has developed a Software and AI as a Medical Device Change Programme it contends will provide ...

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FDA’s Evolving Regulatory Stance For SaMDs, Wearables, Digital Health & DTx

The FDA’s Center for Devices and Radiological Health (CDRH) issued a new policy on April 14, 2020, in an effort to maintain a patient-centric approach to the COVID-19 public health crisis titled Enforcement Policy ...

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Digital Health Apps & SaMD – Incorporating Privacy In Design & Development

John Giantsidis, president, CyberActa, Inc. wrote in the current issue of “meddeviceonline”: Technologies like artificial intelligence (AI) and digital health have made a positive impact in expanding access to healthcare ...

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What Do Artificial Intelligence And Continuous Validation Have In Common?

Kathleen Warner, Ph.D., RCM Technologies wrote in the current issue of MedTechIntelligence: “In 2011, the Center for Devices and Radiological Health (CDRH) initiated the Case for Quality, which provided guidance on how software ...

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AI in MedTech – Risks and Opportunities

An increasing number of medical devices incorporate artificial intelligence (AI) capabilities to support therapeutic and diagnostic applications. In spite of the risks connected with this innovative technology, the applicable regulatory framework does not specify any requirements ...

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MedSysCon Medizintechnik GmbH – Cybersecurity

Securing Medical Devices: What is Really Needed?

Medical device manufacturers continue 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 ...

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MedSysCon Medizintechnik GmbH – ISO 14971:2019, Risk management

ISO 14971:2019 — Clarifying Benefit, Risk, & Benefit-Risk

Discussion of the term “benefit” first appeared in the first edition of ISO 14971, which appeared in 2000. The requirement of controlling risk allowed the use of “benefit” as an alternative method of releasing a product when a residual risk was evaluated as “unacceptable.” ...

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MedSysCon Medizintechnik GmbH, PMS, postmarket surveillance

A Systems Approach to Postmarket Surveillance

Jayet Moon, author of the book “Foundations of Quality Risk Management”, wrote in a Guest Column of Med Device Online: “As the central focus of the EU’s Medical Device Regulations (MDR), postmarket surveillance (PMS) and its related processes and subsystems ...

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MedSysCon Medizintechnik GmbH, ISO 14971, ISO TR 24971:2020

ISO TR 249712020 Brings Clarity To Risk Acceptability In ISO 14971

Edwin L. Bills, member, ISO TC 210 JWG, wrote in the Guest Column on Med Device Online: “Periodically, standards are revisited by international and national committees to determine if they are still current or need revision or withdrawal.

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MedSysCon Medizintechnik GmbH, FDA Digital Health Software Precertification Program

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 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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MedSysCon Medizintechnik GmbH, FDA launches Digital Health Center of Excellence

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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MedSysCon Medizintechnik GmbH, Computer Software Assurance (CSA)

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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MedSysCon Medizintechnik GmbH, DevOps

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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MedSysCon Medizintechnik GmbH, FDA, CSV, CSA

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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MedSysCon Medizintechnik GmbH, MDCG 2019-16, ybersecurity

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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MedSysCon Medizintechnik GmbH, EUDAMED

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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