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Sep

Brazil moves to notification pathway for Class II devices

September 28, 2020Amy SellersNews

Brazil eliminates a premarket approval pathway, instead allowing for premarket notification. Previously, Brazil has had a “Cadastro” pathway to register Class II medical devices and IVDs. This pathway required more extensive documentation (like a technical dossier) for Class II and higher-risk Class I devices. However, on September 18, 2020, the Brazilian regulatory agency, National Health...

Sep

Medical Device Reforms in Australia

September 3, 2020Amy SellersNews

The Therapeutic Goods Administration (TGA), the regulatory body for therapeutic goods in Australia, had previously announced that various medical device reforms would be enacted from 2019 through 2024. The transition period was (and still is) set to end on October 31, 2024. However, this summer, TGA announced a delay in the commencement of the medical device...

Oct

TGA Releases Classification Tool

October 10, 2018Amy SellersNews

The Australian medical device regulatory division TGA has release a new online tool to assist manufacturers with classifying their products. The SME Assist tool “is a dedicated service that TGA offers to help small to medium enterprises (SMEs), researchers, start-ups and those unfamiliar with regulation to understand their regulatory and legislative obligations.”

Feb

China FDA (CFDA) English Website

February 10, 2017Alan KusinitzNews

View the english version of the China FDA (CFDA) website. Formerly the State FDA (SFDA), the CFDA is promoting use of 62304 for medical device software and essentially ISO/IEC 14764 for IT maintenance. It is also actively expanding its requirements related to cybersecurity of networked devices.

Jul

Australian TGA Presentation on Software Regulation

July 5, 2015Alan KusinitzNews

In August 2014, the Australian Therapeutic Goods Authority (TGA) gave a presentation on its approach to software regulation of medical devices. This is a short and very clear high level presentation that explains the TGA’s focus and use of relevant standards such as 62304 as well as its focus on safety and risk management. View...

May

IMDRF Standalone Medical Device Software Draft

May 25, 2015Alan KusinitzNews

The International Medical Device Regulators Forum (IMDRF) SaMD draft of a quality system for Software as a Medical Device is available for public comment.

Feb

IMDRF Documents Webpage

February 13, 2015Alan KusinitzNews

The International Medical Device Regulators Forum (IMDRF) in which FDA participates continues to publish many documents including several related to software.

Sep

IMDRF SaMD Risk Categorization Framework

September 18, 2014Alan KusinitzNews

The IMDRF issued “Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations.” This guidance provides terminology and possible framework for the industry and regulators to work from in discussing and dealing with risk related to standalone software used as a medical device.

Jan

IEC Evaluation of Risk Management

January 4, 2014Alan KusinitzNews

IECEE published Document OD-2044 Ed. 2.2, Evaluation of Risks Management in medical electrical equipment according to IEC 60601-1 and IEC/ISO 80601-1. The procedure intends to provide a uniform approach to the Certification Body Testing Laboratory and Manufacturer on assessment and documentation of compliance with the relevant clauses of IEC 60601 standard series related to the...

Dec

IMDRF Standalone Software Key Definitions

December 9, 2013Alan KusinitzNews

The International Medical Device Regulators Forum (IMDRF) issued a final document “Software as a Medical Device(SaMD): Key Definitions” on December 9, 2013. IMDRF SaMD def

Sep

Australian Regulation of Medical Software and Apps

September 20, 2013Alan KusinitzNews

The Therapeutic Goods Administration of the Australian Department of Health released a document on 13-Sep-2013 entitled “Regulation of medical software and mobile medical ‘apps’.” This explains at a high level Australia’s approach to regulation of medical software. It indicates a risk based approach is taken and that all medical devices are expected to meet the...

Jul

China SFDA Draft Software Premarket Requirements$

July 27, 2012Alan KusinitzBlog, Prem

This content is only available to Premium and higher subscribers. See our Subscribe page for information on subscriptions. The SFDA prepared a draft document entitled "Explanations on the Basic Requirements of Application for Registration of Medical Device Software" on April 28, 2012, which is linked below. This was initially translated to English by JIRA (Japan Industries Association...

Jul

UK NHS Policy Document on IT

July 1, 2012Alan KusinitzNews

This link provides a ten-year strategy document for information technology use in healthcare in England. NHS Power of Information

Jan

Joint Initiative on SDO Global Health Informatics

January 27, 2012Alan KusinitzNews

The Joint Initiative on SDO Global Health Informatics Standardization is formed to enable common, timely health informatics standards by addressing and resolving issues of gaps, overlaps, and counterproductive standardization efforts.

Mar

Draft Chinese SFDA Pacemaker Guidance

March 6, 2010Alan KusinitzNews

Attached is a .pdf of a draft guidance from the Chinese medical device regulatory agency (SFDA) that was sent out for comment. SoftwareCPR reviewed and provided a number of comments. It is one of a number of actions by the SFDA indicating movement to more active regulation of medical devices and the software they contain....

Mar

Korean KFDA Draft Software Guidelines

March 24, 2009Alan KusinitzNews

This link contains an August 2007 draft Korean KFDA guideline entitled “Medical Software Evaluation Guidelines.” This guidance focuses on examining information about the software and what it does, rather than how it may fail or risk management for those failures. There is significant emphasis and specificity in revision numbering and change control. Korea KFDA Software Guideline

Being Agile & Yet Compliant (Public)

Our SoftwareCPR unique approach to incorporating agile and lean engineering to your medical device software process training course is now open for registration!

Agile principles that align well with medical
Backlog management
Agile risk management
Incremental and iterative software development lifecycle management
Frequent release management
And more!

3 days virtual (Zoom) with group exercises, quizzes, examples, Q&A.

Lead Instructor: Mike Russell

Next public offerings:

Americas: 11-13 February 2025
EU/Eastern Europe/Middle East/Africa/Atlantic/eastern South America: 18-20 February 2025
Southern Central Northeastern Pacific: 24-26 February 2025

IEC 62304 and other emerging standards for Medical Device and HealthIT Software

Our flagship course for preparing regulatory, quality, engineering, operations, and others for the activities and documentation expected for IEC 62304 conformance and for FDA expectations. The goal is to educate on the intent and purpose so that the participants are able to make informed decisions in the future. Focus is not simply what the standard says, but what is meant and discuss examples and approaches one might implement to comply. Special deep discount pricing available to FDA attendees and other regulators.

3-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Brian Pate

Next public offering: TBD

Call or email now to schedule a private, in-house class. The fall schedule is filling up!

Email training@softwarecpr.com to request a special pre-registration discount. Limited number of pre-registration coupons.

Registration Link:

TBD

Medical Device Cybersecurity (Public or Private)

This course takes a deep dive into the US FDA expectations for cybersecurity activities in the product development process with central focus on the cybersecurity risk analysis process. Overall approach will be tied to relevant standards and FDA guidance documentation. The course will follow the ISO 14971:2019 framework for overall structure but utilize IEC 62304, IEC 81001-5-1, and AAMI TIR57 for specific details regarding cybersecurity planning, risk characterization, threat modeling, and control strategies.

2-days onsite with group exercises, quizzes, examples, Q&A.

Instructor: Dr Peter Rech, 2nd instructor (optional)

Next public offering: TBD