Medicaldeviceacademy.com

Iterative design is real, waterfalls are illusions

WEBIterative design is real, waterfalls are illusions. 2 Comments / By Robert Packard / May 16, 2023. The Waterfall Diagram was copied by the FDA from Health …

Actived: Just Now

URL: https://medicaldeviceacademy.com/iterative-design/

Risk Management Requirements

WEBFor 510k submissions, the only risk management requirements are the inclusion of risk documentation for devices containing software of at least moderate level risk. There are some exceptions to …

Category: Health Go Health

Risk Classification Process for Health Canada Device Licensing

WEBAuthor reviews considerations of the risk classification process for Health Canada device licensing, including a review of Health Canada guidance documents.. …

Category: Health Go Health

Medical Device Shortage Reporting

WEBThe FDA and Health Canada both have executive-level orders requiring medical device shortage reporting or supply-chain disruptions. In a previous article, we …

Category: Medical Go Health

How to make a supplier questionnaire for remote auditing

WEBTherefore, you should be adding three elements to your supplier questionnaire to assess your supplier’s ability to support a remote audit and to …

Category: Health Go Health

How to create an IVDR checklist

WEBTypically the checklist is in four columns using a tabular form. The left-hand column lists each requirement. The next column is where the auditor documents records …

Category: Health Go Health

Medical Device File Procedure (SYS-053)

WEBCopy of the GHTF Guidance for Summary Technical Documents. SYS-053 Medical Device File Procedure. This procedure defines the format and content for a …

Category: Medical Go Health

Canadian Medical Device Regulations (CMDR): Identifying New …

WEBThe author reviews a few methods to identify changes to the Canadian Medical Device Regulations (CMDR), including using the “compare” function in MS Word. One of the …

Category: Medical Go Health

What is a Gap Analysis

WEBThe Compliance Assessment/Gap Analysis is a singular tool used in the overall maintenance of a quality system. Its actions and performance are similar to a …

Category: Health Go Health

What is a CAPA Board

WEBA CAPA Board should be a cross-functional team of managers that help each other maintain an effective CAPA process. This means: 1) corrections are …

Category: Health Go Health

Design Controls Implementation

WEBRob – While I agree that a disciplined method for defining designs, evaluating hazards, and documenting outputs is absolutely necessary, I’m seriously …

Category: Health Go Health

What's the difference between PMS, PSUR, and PSR

WEBThe PSUR must be available to your notified body, and upon request, the competent authorities. In contrast with the PSUR, Post-Market Surveillance (PMS) …

Category: Health Go Health

Is it required for medical electrical equipment

WEBThe simple answer is yes. In the US, there is a requirement for equipment in the workplace to have an NRTL Safety Agency Approval Mark for the applicable …

Category: Health Go Health

Which Countries Require CE Marking of Medical Devices

WEBSlovakia (2004) Slovenia (2004) Spain (1986) Sweden (1995) United Kingdom (1973) This blog serves as a reference guide with a discussion of, information …

Category: Health Go Health

Obtaining a Health Canada Medical Device License (Case Study)

WEBThis article explains the process for obtaining a Health Canada Medical Device License through a hypothetical case study. Canadian Medical Device Licensing …

Category: Medical Go Health

Risk management policy

WEBISO 14971:2019 includes a requirement for a risk management policy and a risk management procedure. The word procedure is defined (Clause 3.13), a “specified …

Category: Health Go Health

Implant Card Requirement

WEBRegulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices is where the introduction of implant cards can be found. …

Category: Medical Go Health

Post-Market Surveillance Summary Report Webinar

WEBThis live one-hour webinar was recorded on how to prepare post-market surveillance summary reports for compliance with SOR/2020-262. This new Canadian Regulation …

Category: Health Go Health