News & Announcements
We successfully conducted an online training on the requirements of the EU MDR. It was a compressed one-day course that covered the following topics - the framework of the MDR, economic operators and other actors, Eudamed and PRRC, the General Performance and Safety Requirements, QMS, labelling, UDI, clinical evaluation, vigilance and PMS.
PRODUCT LAUNCH ALERT
We are happy to announce the launch of our eQMS software – POLESTAR – A software that’s designed in collaboration with software developers and domain experts.
ISO 13485 Certificate
We successfully completed an online risk management training programme that saw overwhelming participation from several manufacturers located at different locations in the country. The training focussed on risk management as per1 the ISO14971 standard. The entire risk management proces from the identification of hazards, risk analysis, risk evaluation, taking control measures, identifying rersidual risks and conduting a risk benefit analysis was covered. Participants discussed the challenges they faced and valuable insights were provided by the experienced trainers. Contact us for your training requirements on risk management. We conduct both online and onsite trainings. Our trainings come with a lot of practical case studies which can help you build your own risk management file.
ORTHOFOCUS meet up
We successfully conducted an online webinar for orthopaedic manufacturers. The webinar was conducted by experts from the field and actual manufacturers who gave their insights into aspects such as orthopaedic testing, clinical requirements, design aspects and regulatory challenges.
Risk Management Workshop
We recently conducted a Risk Management Workshop for Meril Medical Innovations, equipping their team with practical strategies to identify, assess, and mitigate risks effectively.
