Global Expertise for Medical Devices

Medical Device companies face specific and increasingly complex challenges when it comes to regulatory compliance. Although regulatory compliance has always been required, it has more recently become challenging with implications for RA, QA and Clinical Departments. Celegence provides expertise for every step of the medical device product lifecycle management.
We support in interpreting and operationalizing country-specific requirements with not only depth of experience but also proven processes. Our global team of experts will develop the optimal regulatory strategy depending on the device and market targeted by your organization.
Our global team of scientific writers can support Medical Device submissions including efficient and accurate writing of Clinical Evaluation Reports (CER) to meet the latest requirements.  With a deep level of understanding of the material provided in the each document, we can also bring an added level of speed to your process.

Celegence can help your business with the following dedicated niche offerings:

  • Global Regulatory and Market Intelligence including overviews on country-specific requirements or regulations including product classification, clinical trial study requirements, and import regulations
  • Comprehensive EU MDR support & transition consulting
  • Our experience with CE regulations and clinical literature reviews will ensure that you have detailed process and plan for meeting upcoming changes for Medical Device Reporting
  • Submission support including Clinical Evaluation Report (CER) document writing, CE Labeling, Post Marketing Clinical Follow-up (PMCF) Plans
  • CE Marking projects including classification, clinical evaluation or performance evaluation, validation, technical documentation and post market activities
  • IVDR Classification, Combination Product Classification and filing support
  • Representation and Distributorship servicer for various regions
  • Good Manufacturing Practice (GMP) Compliance & Remediation Services
  • Support with regulatory questions on classification, technical files, device master records (DMRs), Device history records (DHRs), Design history files (DHFs), process validation, software validation and other documentation for reviewers
  • Medical Device Labelling and Review
  • Guidance for Implementation of Unique Device Identification (UDI) and related services
  • Health Agency liaising and support, Authorized representative services

Learn more about our niche service offerings:

REGULATORY LABELING

Maintenance of Labeling Information, including Safety and Efficacy information

PUBLISHING AND ECTD SERVICES

Global Publishing Services and eCTD Conversion

REGULATORY OPERATIONS MANAGEMENT

Managed regulatory operations related to publishing, submission and regulatory information management for reduced total cost of ownership

IDMP & COMPLIANCE CONSULTING

Organizational readiness assessment for IDMP, xEVMPD and UDI compliance and support activities like data collection, maintenance, submission and governance

REGULATORY INTELLIGENCE SERVICES

Proactive monitoring of regulation changes to assess the impact to your product portfolio

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