Medical Device Regulation

Digital Services

Overview

The proposed EU MDR legislation represents an unprecedented regulatory change for the Medical Device sector. With a focus on clinical evidence, transparency, and traceability, it will impact areas such as Clinical, Regulatory, Manufacturing, Supply Chain, and Post Market Surveillance.

 

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Offerings

Medical Device Regulation (MDR) Consulting

Gap Analysis, Amendments/Re-certification, Implementation

Clinical and Post Market Clinical Follow-up (PMCF)

R&D Consulting, Functional Services, CER Updates, and Vigilance

Quality Assurance

Quality Management System (QMS) Implementation, ISO 13485 Update, QSR 21 CFR 820, Risk Management ISO 14971, Corrective and preventive actions (CAPA), Compliance Support

New Product Development

Process Validation, Device Verification and Validation, Computer System Validation

Unique Device Identification (UDI) Compliance

Readiness Assessment, Implementation Support, Conversion Support

Labeling and Packaging

Labeling Analysis, Change Order, Artwork, UDI Compliance, Implant Cards

Digital Modernization

IT Ops/DevOps, Process Automation, Big Data, Insights

 

The Syntel Advantage

 
  • Experience with top 20 medical device companies
  • Preferred partner for device engineering services
  • Labeling and packaging CoE
  • Global and local regulatory experience in multiple therapeutic areas
  • Clinical and PMS domain expertise

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