Medical Devices

Medical device development presents unique challenges to companies seeking approval of novel products. Increasingly impacted by regulatory measures, new technologies, and healthcare economics, companies developing new devices require a disciplined approach to succeed.

Successful product development paths are often guided by thoughtful regulatory, economic and development strategies, as well as meticulous detail to clinical trial execution. From the first stages of getting your device classified by regulatory authorities through market surveillance on your approved product, our team of experienced professionals can help you mitigate risk by navigating regional or global regulations that apply to your device.

At Emmes, the spirit of collaboration and engagement is omnipresent amongst employees in the Rockville, MD, USA office.

Medical Device Services

Emmes offers a variety of global development and commercial services to help advance your medical device from development to commercialization.

Development and Testing

  • Phase I-IV clinical trial management
  • Protocol development and study design
  • Site monitoring services
  • Drafting investigational plans
  • Data collection, management and analysis
  • Development of the pharmacovigilance system
  • Statistical analysis and reporting
  • Regulatory consulting and strategy
  • Preparation of all essential regulatory documents
  • Regulatory filing and publications
  • Communication with regulatory authorities and ethics committees
  • EU Authorized Representative

CE Marking

  • RA/QA Consulting
  • EU Medical Device Classification
  • EU Authorized Representative
  • Technical File Compilation
  • Clinical Evaluation Reports
  • Post-marketing surveillance
  • ISO 13485 Implementation

Phase I-IV, Complex, Rare Diseases Expertise

Sample of Emmes’ Medical Device Experience

  • Laser systems for glaucoma
  • Minimally invasive glaucoma shunts (MIGS)
  • Influenza vaccine/device combination
  • Advanced macular degeneration monitoring device
  • Diabetic retinopathy AI software
  • Reagents for ex-vivo T-cell depletion for GVHD
  • Drug coated balloon PTA catheter for treatment of dysfunctional native and synthetic AV fistulae
  • VytronUS ablation system for treatment of symptomatic drug-refractory paroxysmal atrial fibrillation
  • Remedē® system in patients with central sleep apnea
  • Tempered infusions for induction and maintenance of normothermia in refractory febrile patients
  • Catheter ablation vs. standard treatment for left ventricular dysfunction and atrial fibrillation
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