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Basics of Medical Device Design Controls: What, Why, and How

WEBWhile design control is not required for all medical devices, it applies to nearly every medium- and high-risk device. And this isn’t just for new devices – in the US, FDA …

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URL: https://www.orielstat.com/blog/medical-device-design-control-basics/

The Medical Device Single Audit Program: How to Prepare for (and

WEBThe Medical Device Single Audit Program: How to Prepare for (and Maintain) MDSAP Certification The Medical Device Single Audit Program (MDSAP) is a …

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WEBMedical Device Supplier Quality Management 101. In this paper we review the basics of maintaining quality control of your purchased products while meeting US FDA, EU MDR, …

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Medical Device Design Control 101

WEBMedical Device Design Control 101. A primer on how to properly document your design and development process, track subsequent changes, and understand what’s required by …

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Supplier Management Practitioner

WEBSupplier Management Practitioner Certificate. Supplier Quality Management ‒ or Purchasing Controls, as it is known under Production and Process Controls ‒ is a hot …

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A Guide to FDA Clinical Decision Support (CDS) Software Approval

WEBNovember 1, 2023. A Guide to FDA Clinical Decision Support (CDS) Software Approval. Clinical decision support (CDS) software has become a critical element of healthcare …

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How to Transition Your Medical Device EUA to an FDA 510(k)

WEBHow to Transition Your Medical Device EUA to an FDA 510(k) The COVID-19 public health emergency (PHE) declaration expired on May 11, 2023, which means …

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Medical Device Process Validation 101

WEBEmail. DOWNLOAD THE PDF. Process validation requirements. Validation plans. Writing protocols. Executing IQ, OQ, and PQ. And much more! Oriel STAT A MATRIX explains …

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Medical Device Change Management Process Best Practices

WEBMedical Device Change Management Process Best Practices The one thing that remains constant in the medical device world is the frequency and need for change. …

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You’ve Evaluated Every Risk But Are You Properly Documenting …

WEBOnce you have defined the type of benefit(s) the device offers, you need to assess how substantial that benefit will be. For instance, lets say that you have an ENT …

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Medical Device Quality Systems 101

WEB1095 Morris Avenue Suite 103B Union, NJ 07083. Phone: 1.888.532.6360 Fax: 732.548.4085. International Offices

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What Is a Medical Device Software Bill of Materials (SBOM)

WEBDespite TV shows depicting dramatic attacks on patient pacemakers and insulin pumps, those cases are thankfully uncommon. Kevin Fu, former acting director of medical …

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How FDA Distinguishes Between Medical Device Servicing and

WEBHow FDA Distinguishes Between Medical Device Servicing and Remanufacturing Many medical devices eventually require preventative maintenance or …

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Medical Device Software Validation: FDA and IEC 62304 Compliance

WEBIEC 62304 is the international standard that specifies software lifecycle development requirements for medical devices. Compliance with the standard is mandatory in Europe …

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Medical Device Incident and Adverse Event Reporting Timelines in …

WEBMedical Device Incident and Adverse Event Reporting Timelines in 6 Major Markets Its 3:00 p.m. on Friday and you’re ready for the weekend after a busy week. All …

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Overview of FDA Advertising and Promotion Regulations for …

WEBIntended use is the general purpose or function of a device.; Indications for use refers to the device’s specific clinical application(s), such as the disease or condition …

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Auditing Organization (AO) versus Notified Body (NB) versus …

WEBWith the introduction of the Medical Device Single Audit Program (MDSAP), you may have heard the term Auditing Organization tossed around. It seems like a pretty …

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Medical Device Complaint Handling: Understanding the Basics

WEBMedical Device Complaint Handling: Understanding the Basics For those outside the industry, the term “complaint handling” conjures visions of angry customers …

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EU MDR Vigilance Reporting Requirements and MEDDEV 2.12-1 …

WEBEU MDR Vigilance Reporting Requirements and MEDDEV 2.12-1 Rev 8 Clients often ask us what has changed with regard to vigilance reporting in the European …

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