Regulatory Affairs

Define regulatory strategies to place devices on regulated markets


Prepare technical documentation for regulations such as Indian MDR, EU MDR, US FDA 510K


Develop and implement quality system for regulatory requirements, based on ISO13485, Indian MDR, MDSAP, FDA QSR 21CFR820




Trainings

In-house training on topics related to quality system management and regulatory affairs such as ISO13485, MDSAP, EU and Indian MDR, process validations, risk management, clinical evaluation reports, etc


Develop customized Learning Management Solutions as per customer’s requirements

QA & Regulatory Support

Implement and maintain a quality system as per applicable regulatory requirements


Support to update documentation including Technical Files, Quality Manuals, Procedures, Protocols and Formats


Conduct internal audits and supplier audits


Conduct investigations of customer complaints and non-conformities and take appropriate corrective and preventive actions


Support to maintain an effective post market surveillance system


Support to respond to external audit findings


Identify gaps during updates in applicable standards and regulations

Clinical Affairs

Prepare clinical evaluation reports for submission to regulatory bodies


Design and implement clinical trials and PMCF


Manage Periodic Safety Update Reports




Design & Development

Prepare strategies to design new products


Literature reviews and gap analysis


Prepare design documentation/Design History Files