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Medical Devices

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

Medical Devices

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

Medical Devices

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

Medical Devices

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

Medical Devices

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

Medical Devices

Who regulates your products?

The first step towards bringing your product to the market is understanding which center at the FDA shall regulate your

Medical Devices

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

Medical Devices

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

Medical Devices

Has documentation ever given you a headache?

Here are the most common documentation problems that Elexes has helped its Clients with:  Faulty Document ControlIt

Medical Devices

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

Medical Devices

Importance of Reviews during Medical Device Development

“Continuous improvement is better than delayed perfection” – As rightly said by Mark Twain. Design Review ensu

Medical Devices

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

Medical Devices

Develop — Test — Certify

Testing is the most important element of any medical device development. Comprehensive and successful testing certainly

Medical Devices

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

Medical Devices

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

Medical Devices

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

Medical Devices

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.

Medical Devices

Requisites for EUA qualification

Why was EUA started? The Emergency Use Authorization (EUA) program was first established in 2004 and has a well-defined

Medical Devices

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

Medical Devices

Making Your Voice Heard – CDRH Petition

FDA has the authority to regulate categories of cosmetics, drugs, devices, biologics, and foods. However, during the pro