List of Offerings:
Regulatory Services
● Product Regulatory Strategy Support
● USFDA510(k)Submissions
● Device Listing and Facility Registration
● CE marking as per EU MDR for Class I, IIa, IIb and EU IVDR for Class A, B and C devices
● Registration with India CDSCO such as Import license, Manufacturing license and Wholesale license for Warehouse/ facility
● Free Sale Certificate
● Manage registrations and regulatory compliance in South Asian countries (Singapore, Malaysia, Indonesia, Thailand, Philippines) and South American countries (Mexico, Brazil, etc.).
● Support ISO 27001, HIPAA, and GDPR compliance activities.
● Connect and Coordinate with testing laboratories for compliance testing, including Safety, EMI/EMC, Biocompatibility, and Cybersecurity (Vulnerability Assessment and Penetration Testing- VAPT).
Quality Services
● ISO13485Quality Management System (QMS) Implementation
● ISO Certification Support
● Support with Documentation, SOPs creation, and record generation
● Conduct training sessions on standards such as ISO 13485, ISO 14971 (Risk Management), IEC 62304 (Software Lifecycle Processes), and IEC 62366 (Usability Engineering).
● Support in Product Development and Risk Management. Assist with design and development, verification and validation, risk management, and usability engineering activities.
● Internal Audits
● Conduct gap assessments to identify areas of non-compliance with relevant standards.
● Unique Device Identification (UDI) Implementation
EUMDR Services:
● Clinical Evaluation
● Post-Market Surveillance
● Post-Market Clinical Follow-Up