The European Union Medical Device Regulation (EU MDR) 2017/745 is a regulation that sets out the requirements for medical devices in the EU. The regulation provides the evaluation of medical devices prior to marketing, and one of the key requirements is the need for clinical investigations.

As stated in the European Union Medical Devices Regulations (EU MDR) 2017/745, clinical investigation, is “any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device” The entire purpose of clinical investigations is to demonstrate that medical devices are safe and effective when used for their intended purpose.

Breast milk is the gold standard for infant feeding and nutrition. Lysozyme and Human Milk Oligosaccharides (HMOs), which specifically promote the colonization of infant-type HRB, are among the bifidogenic components of breast milk.

Electronic Product Information (ePI) refers to the electronic version of the Patient Information Leaflet (PIL) that is provided with medicines. The ePI contains important information about the medicine, such as its active ingredients, indications, contraindications, dosing instructions, side effects, precautions, and storage conditions.

Electronic submissions have taken the life science industry's Regulatory space by storm. Majority of the Regulatory submissions are now made using the eCTD format globally. The benefits of eCTD are undeniable - faster, more efficient, and standardized. But transitioning from non-eCTD electronic Submission (NeeS) to eCTD isn't always a cakewalk.

Audits and adherence to dynamic regulations have posed serious challenges for various pharmaceutical organizations. To list down the forthcomings of pharma audits, FDA warning letters and compliance adherence letters are endpoints, thereafter the compliance bridging is in the hands of pharmaceutical companies.

Post-approval change management is the process of monitoring and maintaining the safety, effectiveness, and performance of a medical device after it has received Regulatory approval and has been placed on the market. This process involves continuous evaluation and management of changes to the device, including changes to its design, labeling, manufacturing, and usage.

ANVISA comes up with a new resolution, RDC 751, effective from March 01, 2023. The Resolution defines the risk classification rules for medical devices, labeling requirements and Instructions For Use (IFU), and the procedures for notification, registration, amendment, revalidation, and cancellation of notification or registration of medical devices. It revokes RDC no. 185/2001, RDC no.15/2014, and RDC no. 40/2015.

Meta-analysis is a subset of systematic reviews that combines pertinent qualitative and quantitative study data from several selected studies to develop a single conclusion with greater statistical power. This conclusion is statistically more significant than the analysis of any single research due to the increased numbers of subjects, greater diversity among subjects, or accumulated effects and results.

Are high-interest rates, rising inflation, and unpredictable economic climate influencing your organization’s downturn? According to one of the reports, the medical science industry will necessitate seventy thousand (70,000) Regulatory roles over the next decade. Filling these positions has been and will continue to be a challenge for the industry.