Medical devices – addressing a changing regulatory environment

The regulatory environment for medical devices companies is becoming more complex, requiring companies to understand and adapt to new requirements. An example is the Medical Devices Regulation (MDR) in Europe, which replaces directives and comes into force in 2020. These new regulations, along with changing expectations globally, place additional pressure on regulatory, quality, and clinical departments.

Celegence – global expertise for medical devices

Celegence provides expert medical device regulatory consulting for every step of the product lifecycle. Our proven processes help you interpret and meet country-specific requirements. Our global team of experts will develop the optimal regulatory strategy, depending on the device and market targeted by your organization.

Our team of scientific writers can handle all your medical device submission requirements, including carrying out all Clinical Evaluation Reports (CER) writing on your behalf. And our deep knowledge of the regulations and processes allows us to speed up the registration and submission process.

Celegence helps you meet changing medical devices requirements with the following niche services:

  • Global regulatory and market Intelligence including overviews on country-specific requirements or regulations including product classification, clinical trial study requirements, and import regulations
  • EU MDR consulting services to support transition to the new regulations
  • Assessment of Post-Market Clinical Follow-up study requirements for your device and assistance with the developing a plan, designing the study, and conducting data analysis
  • Expert guidance on CE regulations and clinical literature reviews to help you meet changes for MDR
  • 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
  • Guidance for Implementation of Unique Device Identification (UDI) and related services

Learn more about our niche service offerings:

MEDICAL WRITING

Medical writing – delivering specialty knowledge

REGULATORY LABELING

Regulatory labelling – supporting clients from creation to maintenance

PUBLISHING AND ECTD SERVICES

Publishing and eCTD services – tackling global submission challenges

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

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