In today’s rapidly evolving regulatory and quality assurance landscape, medical device companies struggle to comply with regulations across nations. Businesses are not only stretched for bandwidth of in-house resources who may lack expertise on how the regulations are changing, but also on their implications. Non-compliance leads to product recalls, legal costs, and can impact a company’s brand.

Cyient has helped over 12 medtech firms seamlessly comply with new regulations, establish or enhance the quality management system, and enable internal resources to focus on their core expertise.  Our experienced team has successfully launched medical devices in multiple countries, including USA, Europe, India, Singapore, and Canada, in accordance with local regulatory requirements. We have established, documented, and maintained an effective quality management system that meets the requirements of ISO 9001 and ISO 13485:2016. In addition, we are actively helping customers successfully comply with EU Medical Device Regulations (MDR) and In-vitro Diagnostics Regulations (IVDR).

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  • Quality Assurance Icon
    Quality
    Assurance
  • Regulatory Compliance Icon
    Regulatory
    Compliance

  • Remediation
  • Corrective action/preventive action
  • QMS development
Quality Assurance Icon

  • Product design control
  • Supplier quality assurance services
  • QSR compliance with 21 CFR 820

  • IVDR and MDR compliance
  • Country specific regulatory filings and submissions
  • Environmental compliance (RoHS, REACH, WEEE)
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  • Risk management services per ISO 14971
  • Responding to FDA 483 observations, warning letters, and Notified Body audit findings
  • Post Approval Change Control


The Right Expertise to Navigate EU Medical Device and In-Vitro Diagnostics Regulatory Compliance

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EU Medical Device Regulations

Cyient can support the complete transition from MDD to MDR, right from gap assessment through post market surveillance, technical documentation, and DHF and RMF preparation.

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EU In-Vitro Diagnostics Regulations

Cyient is helping customers navigate the complexities involved in IVDR implementation to successfully meet the May 2022 deadline.

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Our Success Stories

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Established a Regulatory Center of Excellence

We have established a Regulatory Center of Excellence for one of the top IVD companies, supporting them to comply with In-vitro Diagnostic Regulations (IVDR).

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A Successful Remediation Engagement with a US-Based Orthopedic Company

Established a successful remediation engagement with a US-based Top-5 orthopedic company. Remediated 28,000 SKUs for implants, instruments, cases, and trays within 15 months to ensure compliance with FDA standards.

The Cyient Advantage


  • Design house and manufacturing unit in compliance with ISO 13485:2016 quality management system
  • Flexible ramp-up and ramp-down of resources in accordance with customer’s needs
  • Partnership with Underwriters Laboratories( UL) and Technischer Überwachungsverein (TUV) for testing
  • Robust documentation capabilities supported by ready-to-use templates for faster time-to-market of compliant products
  • Highly experienced team of 50+ quality and regulatory experts with extensive domain knowledge in medical devices and IVD

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