The Qmed Podcast

Qmed Consulting

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MEDICINE
MONTHLY

Ready to move into the MDR space? This podcast is for you, if you’re facing challenges within all stages of getting a product to market. To help you we’ve gathered some of the greatest and most influential minds in the Medical Device industry, to get their insights on how to go from an idea to a market success. You'll be accompanied by our host, Helene Quie, the founder and CEO of Qmed Consulting.

5 DAYS AGO

S5 E5: Academy Talks: Medical Device Documentation: Clinical Evaluation

We will walk through the clinical evaluation process starting with the clinical evaluation plan and the literature search as the initial steps to identifying the clinical safety and performance objectives. These two procedures are built on a vigilant search of publicly available databases and establishing a state of the art description of similar and equivalent clinical procedures and devices. The output is the clinical evaluation report. We will additionally walk through who can and when to establish the process of clinical evaluation and how to continuously update the documentation.

25 min
15 NOV

S5 E4: Academy Talks: Medical Device Documentation: Risk Management

This session will walk you through the overall risk management process. Starting with the description on the risk management plan and how to work with the risk management analysis/HTM matrix. This process is built on several input sources that we will highlight during our discussion and finalise in our risk management report, identifying the final residual risks. The risk management documentation is evaluated during the risk management review process as established in the companies. We will finally highlight how to update the ongoing risk management documentation.

21 min
8 NOV

S5 E3: Academy Talks: Medical Device Documentation: Requirement Specifications

Now that you have your user needs description, we will walk you through how to set the user and device related requirements supported by the list of applicable standards and the device description. Once we have this in place, we will be able to define our clinical claims and clinical and non clinical objectives, Again, we highlight the importance of updating the ongoing documentation throughout the development process.

17 min
1 NOV

S5 E2: Academy Talks: Medical Device Documentation: User Need

We will continue the development of the device description and based on that define our intended user and patient population. We will also discuss what input sources to use and how to create the specific documentation. We will also touch on concept testing that can be used to develop the early stage documents. We will walk you through how to update your user input documents.

17 min
25 OCT

S5 E1: Academy Talks: Medical Device Documentation: Stand Alone Documents

In our first episode, we will discuss the importance of the device description and the link to the other standalone documents, such as classification, GSPRs, regulatory compliance plan, instructions for use and the list of applicable standards. This will enable you to start out on the right foot with your medical device development project. We hope you find this series helpful! You are so welcome to let us know your thoughts and if you have any questions by commenting below or emailing us at QmedPodcast@gmail.com.

27 min
23 OCT

Academy Talks: Medical Device Documentation

The Qmed Podcast

1 min
8 FEB

S4_E2_PMCF survey with CETAS Healthcare

During this episode we will have CETAS Healthcare share their extensive knowhow and perspective on how to set up PMCF surveys and gather important data fulfilling the MDR requirement.

1h 4m
13 JAN

S04 E01 Biocompatibility with Ted Heise

Ted Heise from the MedInstitute is a true subject matter expert within biocompatibility and biological evaluation. He will share during this interesting conversation his view on how to understand the guidances and regulations in the key markets.

33 min

See All (41)

Creator

Qmed Consulting
Years Active

2019 - 2024
Episodes

41
Rating

Clean
Show Website

The Qmed Podcast

The Qmed Podcast

S5 E5: Academy Talks: Medical Device Documentation: Clinical Evaluation

S5 E4: Academy Talks: Medical Device Documentation: Risk Management

S5 E3: Academy Talks: Medical Device Documentation: Requirement Specifications

S5 E2: Academy Talks: Medical Device Documentation: User Need

S5 E1: Academy Talks: Medical Device Documentation: Stand Alone Documents

Academy Talks: Medical Device Documentation

S4_E2_PMCF survey with CETAS Healthcare

S04 E01 Biocompatibility with Ted Heise

About

Information

The Qmed Podcast

Episodes

S5 E5: Academy Talks: Medical Device Documentation: Clinical Evaluation

S5 E4: Academy Talks: Medical Device Documentation: Risk Management

S5 E3: Academy Talks: Medical Device Documentation: Requirement Specifications

S5 E2: Academy Talks: Medical Device Documentation: User Need

S5 E1: Academy Talks: Medical Device Documentation: Stand Alone Documents

Academy Talks: Medical Device Documentation

S4_E2_PMCF survey with CETAS Healthcare

S04 E01 Biocompatibility with Ted Heise

About

Information