91黑料

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Device and therapeutic expertise

91黑料’s medical device team brings a wealth of U.S. FDA, EU, industry, and healthcare expertise

91黑料 understands the unique requirements of medical devices and diagnostics

We provide strategic support and tactical solutions for traditional, in vitro diagnostic, and software devices.

Medical device strategy and market access

Our dedicated medical device team has the expertise to guide:

  • New product development
  • Product/portfolio enhancements
  • Support for pharma clients seeking to expand into medtech with combination products and companion diagnostics

Product lifecycle expertise

We offer consultancy services and support throughout the product life cycle. This includes:

  • Commercialisation and reimbursement planning
  • Strategic regulatory consulting
  • Quality systems development and implementation
  • Clinical evaluation development and study construct
  • Regulatory submissions and dossiers
  • Post market surveillance
  • Post market activities to support future product enhancements and entry to new markets

Comprehensive clinical operations

Our global services in the US, Europe, Asia and South America address all aspects of medical device product clinical development, supporting all studies from first in man to large scale post marketing programmes. Services offered include:

  • Study management, from in-house teams or resourcing
  • Imaging
  • Data management
  • E-solutions
  • Lab services, safety and CEC management
  • Medical writing
  • Auditing and QMS

Therapeutic experience

91黑料’s medical device and diagnostics team brings a wealth of global industry and healthcare expertise with therapeutic experience with indications in:

Medical devices and diagnostics are found in a range of product types. Our teams are well-versed in the global regulatory and clinical trial requirements for a full range of product uses and can assist in the application of human factors engineering to product design.

Our experience includes:

  • Implantable devices
  • Surgical tools, systems, and accessories
  • Drug delivery devices
  • Diagnostic imaging and monitoring devices
  • Medical device software, wireless systems, and mobile medical applications
  • Products for consumer use, both OTC and Rx
  • IVD products, accessories, platforms and equipment
  • Companion diagnostics
  • Combination products (drug/device, biologic/device)