project meeting background

We provide our clients with

regulatory, quality, and clinical

consulting services of highest caliber

 

Areas of Focus

Digital Health

AI/ML

Regulatory and

Clinical Strategies

Premarket

Review

Quality Management System

Advertising & Promotion Compliance

Postmarket Compliance

REGULATORY SERVICES

  • Medical device status determination

  • Device classification

  • Indications for use and target claims

  • Regulatory pathway determination

  • Predicate device and competitor device research

  • Special control proposal for 510(k)

  • Breakthrough and STeP device designation

  • FDA pre-submission ("Q-sub") meeting request and preparation

  • Pre-market submission (510(k), De Novo, PMA, HDE)

  • FDA deficiency response

  • Advisory committee panel meeting preparation

  • U.S. agent and FDA communications

  • Labeling, ad/promo, and social media compliance

  • EU medical device regulation (EU MDR)

US government building
digital health app

QUALITY SERVICES

  • Quality strategy

  • Quality system setup and assessment

  • Risk assessment

  • Cybersecurity

  • Human factors engineering and usability evaluation

  • Data privacy

  • Corrective and preventive action (CAPA) support

  • Field corrective action (FCA) determination and preparation

  • Inspection preparation and support

AI and Machine learning app

CLINICAL SERVICES

  • Clinical requirements determination

  • FDA negotiation on pre- and post-approval clinical strategies

  • Study protocol development

  • Significant risk (SR), non-significant risk (NSR) and exempt study determination

  • Biostatistics, data management and data programming

  • IDE application

  • Clinical operation support

  • Clinical evaluation report (CER)

  • Bioresearch monitoring (BIMO) inspection preparation