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Nicholas started the discussion Now hiring at MEDIcept – Sr. Regulatory Consultant in the forum IndieMedTech 6 weeks ago
Now hiring at MEDIcept - Sr. Regulatory Consultant
Hi Everyone,
In case you haven’t heard of MEDIcept, we are a small Consultancy and CRO for the Medical Device Industry. Due to popular demand of SaMD and SiMD experience, our Regulatory team is growing! It is a salaried position with benefits. Please reach out if you would like to learn more! nradoux@medicept.com
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Purvi joined the group
indieFeed 7 weeks ago -
Holly replied to the discussion ISO 10993-1:2025 in the forum IndieMedTech 7 weeks ago
I have also been hoping for some more information on this and guidance on how to raise this with clients so we can adequately anticipate any impact to testing strategies?
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Daria started the discussion ISO 10993-1:2025 in the forum IndieMedTech 7 weeks ago
I see that ISO 10993-1: 2025 is under publication and will be releasing soon, and that the US voted “NO” for the changes. I can’t find any intel about what specific clauses the US objected to other than “cumulative use” (how repeated uses of a device add up in exposure) which will significantly revise (increase) the contact duration and…
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Garrett joined the group
indieFeed 7 weeks ago -
Holly posted an update in the group
indieFeed 7 weeks agoDid anyone see this? Zimmer Biomet sues Deloitte over disaster implementation of an enterprise resource planning software for $172M – this is pretty wild to see such a huge lawsuit over essentially ineffective consulting support. Will be interested to see how this plays out.
Link here: https://www.massdevice.com/zimmer-biomet-sues-deloitte-for-172-million/
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I did, I read an article about how consulting firms have promised a great deal regarding AI and then have provided little to no results. Although the Deloitte issue was an ERP system. I think the principle is the same overpromising and underdelivering. In the end I think the lawsuit will be dropped for additional support. But we will…
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Overpromising and underdelivering – the key!
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Melissa replied to the discussion Medical device? in the forum IndieMedTech 8 weeks ago
Hi@AmieSmirthwaite – I definitely agree with Holly to check out FDA’s guidance for general wellness. When you consider regulation and classification of many of these types of devices in the US, the question often becomes whether or not the organization marketing the device has vetted their regulatory strategy (as a class I, 510(k) exempt or…
Holly -
Pamela joined the group
indieFeed 8 weeks ago -
Holly posted an update in the group
indieFeed 8 weeks agoSpotted: Something new is here for our community!
We’re excited to share Monir El Azzouzi new MedTech magazine—a resource created to spotlight the latest QA/RA ideas, innovations, and voices shaping our industry.
At indieMedTech, we believe knowledge is best when it’s shared. This new publication is another way to bring the community…
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Niki replied to the discussion Event Announcement for this amazing forum! in the forum IndieMedTech 8 weeks ago
Reply to Event Announcement for this amazing forum!
I can’t wait for this event!
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