AI/ML-based Software as a Medical Device (SaMD)-An urge for perfection
As rightly said, “Perfection is not attainable, but if we chase perfection we can catch excellence.” The urge to cre
Breakthrough vs. STeP, which one is more apt for your medical device?
Both STeP and Breakthrough Device Program comprises 2 Phases. In the first Phase, sponsors formally request inclus
Clinical trials in South Africa – worldwide accepted data
Clinical trials being a resource, cost, and time extensive process, identifying the right location for a clinical trial
RUO – A Market Opportunity for IVD companies
Getting an IVD product to the market is a cumbersome task and takes several months to over a year to finally get everyth
Official Number is now 15 – MDD to MDR + IVDD to IVDR Planning
Everyone knows that the advent of MDR was postponed, and the new regulation shall be in full force from May 26, 2021. As
All Pandemics are 100 years old and innovation is older
“O lost, and by the wind grieved, ghost, come back again.” as rightly said by Thomas Wolfe; the globe faces a deadly
Who regulates your products?
The first step towards bringing your product to the market is understanding which center at the FDA shall regulate your
List of EU Notified Bodies designated under the EU MDR and EU IVDR
EU Notified Bodies designated under the EU MDR (2017/745) Sl.No. Notified Body Name Notified Body Location Notified Body
What Life Cycle model shall you choose for your SaMD?
Software Development Life Cycle (SDLC) is the most important element of a Software as a Medical Device (SaMD)Quality Man
Has documentation ever given you a headache?
Here are the most common documentation problems that Elexes has helped its Clients with: Faulty Document ControlIt
Successful Certification and Maintenance
The road to certification w.r.t. ISO 13485 and MDSAP is certainly a long one, but with systematic planning and execution
Importance of Reviews during Medical Device Development
“Continuous improvement is better than delayed perfection” – As rightly said by Mark Twain. Design Review ensu
Money matters in the device world
When crafting a budget for your medical device development and launch, it is important to know the primary sources of mo
Develop — Test — Certify
Testing is the most important element of any medical device development. Comprehensive and successful testing certainly
Rush or Wait? The EUA Dilemma
FDA Emergency Use Authorization (EUA) program is a great way to help out in an emergency situation, whether it is for di
Know the differences for proactive planning – MDD to MDR
The new Medical Device Regulation has been postponed by a year, however, the regulation is still coming and all medical
PPE to the Rescue! Requirements – EU and USA
A lot of companies are being asked by their government to make PPE to help during COVID crisis, and many are choosing to
Every single day matters!
When companies are looking to get their product to the market, they certainly want to get it there as soon as possible.
Requisites for EUA qualification
Why was EUA started? The Emergency Use Authorization (EUA) program was first established in 2004 and has a well-defined
Can I file A CDRH Petition?
FDA ratifies more than 200 petitions annually and only a few are successfully filed in the system. Anyone can file
Making Your Voice Heard – CDRH Petition
FDA has the authority to regulate categories of cosmetics, drugs, devices, biologics, and foods. However, during the pro
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