With the aid of biotechnology, we are living in the era where biological products, large complex molecules, are extremely common. These products may be produced in a living system, such as a microorganism, plant cell, or animal cell, and are often more difficult to characterize than small molecule drugs. Categories of Biologics are as follows:

  • Allergenics
  • Blood & Blood Components,
  • Cellular & Gene therapy products,
  • Tissue & Tissue products,
  • Vaccines, and
  • Xenotransplantation

When planning to develop a biological product and bringing it to the market it’s important to know of the various regulatory pathways outlined below. Each regulatory pathway has…


Clinical trials being a resource, cost, and time extensive process, identifying the right location for a clinical trial is paramount. Republic of South Africa (RSA) is one such location that can be apt because:

  • RSA, a Tier 1 country for the USFDA, is exempted from export notification for Investigational Devices per 21 CFR 801(e)(2) and the IDE regulations as long as the SAHPRA requirements are met
  • RSA clinical trial results can be used to support marketing authorization in developed countries, as RSA regulatory framework and standard of care are highly credible
  • The country offers a diversified patient population which is…


Getting an IVD product to the market is a cumbersome task and takes several months to over a year to finally get everything in place, especially with regards to testing and data collection. Research Use Only is a unique marketing opportunity which is generally less explored. Here is something by Elexes to help IVD companies understand more about RUO and how the pathway can be utilized to get traction while other activities are being pursued.

#elexes #ivd #regulatory #documentation #labeling #qms #fda #reporting #clinicaldata #manufacturer #performance #usability #misbranding

RUO — A Unique Market


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 we prepare for this change, keeping abreast of updates shall help in efficient planning.

Another NB GMED just got added to the list of Notified Bodies accredited to do the reviews of technical files under MDR. The addition of more NBs will certainly make the process of transitioning from MDD to MDR more manageable and practical. It’s important to know the differences between…


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

  • CDRH — Center for Devices and Radiological Health
  • CDER — Center for Drug Evaluation and Research
  • CBER — Center for Biologics Evaluation and Research

While for most products a categorization between drugs, biologics, and medical devices is easy, in some cases this can be a challenge, especially if a product is a consumer product or mobile app with medical application or a combination product, injection, drug delivery system, etc. …


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 pandemic every 100 years.

COVID this year has been very difficult for everyone around the world, with people not being able to move around, some families being apart in different locations for a long period of time, kids staying at home when they should not be restricted from going out, and healthcare professionals working day and night to meet the ever increasing burden on the healthcare system. …


Software Development Life Cycle (SDLC) is the most important element of a Software as a Medical Device (SaMD) Quality Management System (QMS). The right model should be identified considering:

  • The uniqueness of your SaMD and its intended use
  • The kind that will work for your team
  • The level of information to be made available at each stage to proceed
  • The time & cost constraints with which you have to work to reach design freeze

Some practical challenges -

Defining all requirements upfront

Defining all the specifications and requirements at the start of the development can be difficult due to the…


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

Faulty Document Control
It’s common to have a working document that everyone contributes to, but this can backfire when everyone makes revisions in different versions of the original document.

Communication between teams
The communication between the regulatory and the Product development teams can be tricky and can turn into a blame game very quickly.

Unmanaged SOP Changes
Producing, validating, and officiating changes in SOPs takes time, and is a process involving multiple people and groups.

Unwieldy Documents
Small and precise documents can turn into unmanageable ones when multiple groups make substantive edits to them.

What has been the most common problem that you faced?


The road to certification w.r.t. ISO 13485 and MDSAP is certainly a long one, but with systematic planning and execution various milestones can be timely and successfully achieved.

For companies looking to get a Quality Management Systems (QMS) Certification in accordance with ISO 13485 or MDSAP (recognized by Canada, Japan, US, Australia and Brazil), the first step is to get a complete set of procedures, work instructions, and forms in place, and implement them, next step is to conduct internal audit, and then Management Review Meetings (MRM) to demonstrate management commitment for quality.

It’s important to know that each of these certifications…


Testing is the most important element of any medical device development. Comprehensive and successful testing certainly helps confirming that the product would work as intended and shall be reasonably safe and effective when used. Given that right tests were performed, the product would also get through the approval process swiftly. Everyone recognizes the importance of clinical validation, however there exist some common questions around certification testing.
“What testing should I do for the product?”
“What testing does the FDA want to see?”
“How many tests shall I run for the product?”
“What do I need to perform my testing against?”
The answer to many of these questions lies in the device’s technology and intended use. Here are some typical device characteristics and the corresponding internationally recognized standards that allow thorough planning and execution of testing.

Parul Chansoria

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