ASELL partners and collaborates with developers to advance technologies to strengthen global health and emergency preparedness. With deep expertise in medical device development, ASELL’s team of experts can assist you in advancing your technology from early-stage development through product delivery. Our services include providing quality and regulatory advisory services, conducting clinical studies and supporting regulatory submissions, forming integrated partnerships to pursue and execute government programs, and providing other product development support services to suit our clients’ needs. Each engagement is tailored to best meet shared organizational goals. Please contact us if you would like to explore how we might work together.

Regulatory Affairs Support

A successful regulatory submission is essential in moving a medical device to market.   ASELL provides regulatory affairs support from initial development of a regulatory strategy that aligns with your business objectives through post marketing support. We provide assistance in preparing and reviewing materials and facilitate interactions with FDA. Our team includes former FDA personnel and has deep expertise in FDA and EU regulatory paths across a breadth of medical devices.

We can support you in:

  • Development of Regulatory Strategy
  • Pre-Submission and Submission Preparation
    • Emergency Use- Authorization
    • Breakthrough Device Designation
    • 510k, de novo, PMA
  • FDA Engagement
    • Meeting preparation
    • Crafting communications

Quality Management

A structured quality management system is a critical element to achieving and maintaining regulatory clearance for any medical device. For both early stage and established companies, ASELL provides quality management system support.

Our team provides expertise and services in:

  • Development and Implementation of an appropriately scaled Quality Management System
  • Quality Manual and SOP development
  • QMS training
  • FDA Quality Systems Regulations (CFR 820)
  • ISO 13485
  • Audits
    • Internal audits
    • Supplier Audits
    • External audit prep
    • Audit support

Clinical Research

From early-stage feasibility testing through final validation, clinical studies are integral to the development of in vitro diagnostics. Our team brings proven experience across the disciplines needed to successfully conduct your clinical study.

Our services include:

  • Clinical Study Project Management
  • Study design, Protocol Development and Review
  • IRB submissions and amendment management
  • Site and Lab management
    • Identification and Selection
    • Qualification and Training
    • Monitoring
  • Trial Master File creation
  • Data Management, Analysis and Reporting
  • Usability Testing
  • Clinical Performance Testing from feasibility through validation

Product Development

Successful development of a medical device demands more than great science and engineering. It requires the achieving technical objectives within a framework of quality management and regulatory requirements and within the schedule and budget driven by business factors. ASELL’s team of experienced product development managers can assist you in developing and implementing a plan that balances these elements.

Our services include:

  • Product Roadmap and Development Planning
  • Program Management
  • Risk Management
  • Partner and Vendor Management
  • Scientific advice and support

Government Contracting

The US government invests billions of dollars annually in technology development and is a potential source for non-dilutive funding to advance your medical device. The complexities of identifying specific funding opportunities, engaging the government agencies, generating a successful proposal, and executing a federally-funded program can be daunting to many. ASELL has our roots in federal contracting and has the deep experience and fully compliant systems needed to capture and successfully deliver on federally funded programs. We have the expertise to navigate the federal landscape and can provide the assistance and partnering necessary to empower you to leverage federal dollars to advance your technology and company.

Our expertise includes:

  • Identifying funding targets
  • Federal client outreach
  • Capture Planning
  • Proposal Development
  • Federal Contracting and subcontracting
  • FAR compliant accounting system
  • Earned Value Management

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