Medical Device – Regulatory & Product Intelligence

The Medical Device industry is one of the largest industries in the healthcare sector, with significant growth in the last few years. The industry is undergoing continuous transformation to comply with the ever-changing regulations introduced by global Regulatory Authorities, to ensure strict controls over device performance and safety. In such a scenario, having a better understanding of the Regulatory environment and updated Regulatory information, to design and implement a good strategy can result in reduced costs, reduced time-to-market, and maximum compliance. Device manufacturers’ requirements of Regulatory, Quality, and Compliance are of equal weightage. In order to make product registration or changes, regulatory, quality and compliance needs to be assessed at the same time. Traditionally, gathering regulatory intelligence requires months of research. Industry consultants can provide insight but are often slow to respond due to a high volume of inquiries or their own lack of knowledge about individual products or region-specific requirements.

ViSTAAR utilizes technology (enabled by AI) and global subject matter experts to align Broader and Deeper datasets to the needs (in the form of reports, searches, alerts, and monitoring). It provides the most comprehensive, up-to-date regulatory intelligence, which includes up-to-date regulatory requirements, gap assessment, standards, and regulatory monitoring on the web. These are condensed into easy-to-follow steps and translated to English when and wherever necessary.

ViSTAAR Expertise

1. Regulatory requirements for Devices, Diagnostics, Digital Health, SaMD, and Combinational products.
2. Manually reviewed regulatory summaries covering clinical, technical, QMS/Quality, market launches, testing standards, submission checklists, fees, labeling, import/export, marketing, safety/Vigilance, life cycle requirements, and many more areas in a granular manner.
3. Compare countries or specific areas side-by-side and download in the format of user preference.
4. Global up-to-date technical standards and subscribe to alerts.
5. 1.2 Million Global document repository of health authorities’ regulations and guidance updated daily and provided to you with AI-enabled search for faster and better matches.
6. Global clinical trials gathered from global registries to see all clinical activity.
7. Comprehensive Regulatory Intelligence report on all the Regulatory requirements including market trends and forecasts for a country
8. Country-wise updates for Medical Devices and Diagnostics covering the Regulatory news and their anticipated impact and recommendations
9. Timely alert to client in case any prompt action is required 

Standards (Quality Standards for Med Device companies)

Keeping up to date with required standards is key for medical devices to be compliant in different countries. As standards are developed by several agencies/bodies, keeping track of all the associated questions as who’s updating and what is being updated has always been a manual and time-consuming task. VISTAAR Standards module keeps you current on the standards on each and every update along with the current versions with extensive details.

Approved Medical Devices Insights

A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval (PMA).

ViSTAAR utilizes AI-enabled technology and extracts the information of all the 510k labels. Users can subscribe for alerts based on their requirements and timely alerts help users in case any prompt action is required. Users can search device 510(k) labels by 510(k) number, Product code or Device name, medical specialty indications for use and manufacturer. It provides detailed information which includes:

1. Device Classification Name
2. 510(k) Number
3. Device Name
4. Applicant
5. Product Code
6. Decision Date
7. Decision
8. Classification Advisory Committee
9. Review Advisory Committee
10. Device Summary