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


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