To define your pathway and deliver your major milestones, Veranex’s regulatory and quality experts are recognized for their well-established and strong relationships with the FDA, European Medicines Agency, and other international regulatory agencies.

With our track record of successful regulatory submissions in medical devices, in vitro diagnostics, software as a medical device (SaMD), and combination products, we’ll help you determine the optimal regulatory pathway to successfully navigate the submission process.

We also provide full-service quality consulting services to our clients, supporting the development, implementation, and maintenance of clients’ quality management systems, design control support, design history file (DHF) activities, and preparation for and performance of audits/inspections and supplier quality assessments. To optimize your investment, trust our regulatory and quality expertise specifically focused on your MedTech innovation.

Meet the Veranex Regulatory Affairs and Quality Management Experts

For Regulatory Guidance and Quality Management, Veranex Is Your Difference

Our Capabilities

We recognize the criticality of the U.S. market for medical device companies. We facilitate early FDA interactions and lead FDA regulatory submission efforts to ensure alignment for efficient, successful program outcomes. Our team works with every division within the Center for Devices and Radiological Health (CDRH), as well as the Office of Combination Products, Office of Compliance (OCP), and Office of the Center Director.

Services:

  • U.S. regulatory landscape assessments
  • U.S. regulatory strategies
  • Breakthrough device designation applications
  • Safer technologies program (STeP) applications
  • Digital health software precertification review
  • Prepare and facilitate Q-submissions (pre-submissions, submission issue requests, study risk determinations, informational meetings, PMA Day-100 meetings, agreement, and determination meetings, etc.)
  • Investigational device exemption (IDE) (early feasibility, feasibility, pivotal, and IDE supplements)
  • Premarket notifications 510(k) (traditional, special, and abbreviated)
  • De novo applications
  • Premarket approval applications (PMA) (original, modular, and PMA supplements)
  • Humanitarian use device (HUD) designation/humanitarian device exemption (HDE) application
  • FDA progress reporting (IDEs, HDEs, and PMAs)
  • Complaint processing/medical device reports
  • Regulatory compliance inspections (QSIT, pre-approval, BIMO)
  • External standards and guidance maintenance
  • FDA interface (for meetings and regulatory submissions)
  • FDA establishment registration and product listing
  • Labeling (product, IFUs, unique device identification [UDI] operator manuals)
  • Letter-to-file assessment
  • Field actions and recall advisory support
  • Regulatory release of products (investigational and commercial)
  • Regulatory review of marketing materials and website
  • State of California Food and Drug Branch (FDB) license registration

We help clients strategize around market authorization and market entry opportunities in multiple geographies and help you navigate the regulatory requirements for each. We work with most every major Notified Body and Competent Authority/international regulatory agency in the world.

Services:

  • Global regulatory strategies
  • European Union Medical Devices Regulation 2017/745 (EU MDR) technical documentation
  • Clinical evaluation plans/reports (CEPs/CERs)
  • Change notice assessment
  • External standards
  • Health Canada license support
  • Health Canada submissions
  • Individual country submissions (e.g., TGA, ANMAT, ANVISA, PMDA)
  • Labeling (products, IFUs, UDI, operator manuals)
  • Field actions and recall support
  • Regulatory release of products (investigational and commercial)
  • Regulatory review of marketing materials and website
  • Self-certification support
  • State-of-the-art updates for technical documentation
  • Vigilance/incident event reporting

Veranex understands quality goes beyond the device itself. It includes developing an appropriate Quality Management System (QMS), implementing the system, and ensuring continuous improvements throughout the total product life cycle. With more than three decades of experience behind us, Veranex will help you achieve consistent quality compliance.

Services:

  • Develop quality management system (QMS) strategies
  • Gap assessments of client QMS
  • Design control support
  • Project management support
  • Risk management support
  • Verification and validation (V&V) master plans
  • Design history file (DHF) assessment/management
  • Technical support for product testing (performance, electrical and mechanical safety, transit/packaging, sterilization, cleaning, disinfection, biocompatibility, human factors/usability, software and firmware, cybersecurity, products derived from tissues of animal origin)
  • Facility design, maintenance, and transfer support
  • Process validation and revalidation, including controlled environment and clean room commissioning support
  • Ongoing QMS maintenance (management and annual product reviews, CAPAs, nonconforming materials, training, suppliers, etc.)
  • QMS documentation development
  • QMS implementation
  • Training
  • Audits (ISO 13485, IEC 62304 (software), quality system inspection technique (QSIT), preapproval inspection (PAI), medical device single audit program (MDSAP), EU MDR, supplier, internal, etc.)
  • Agency inspection/audit preparation and support: FDA, CA FDB, notified bodies, international (e.g., Canada, China, Japan, Australia, Brazil, Korea, etc.)
  • Inspection/audit response and remediation support (including FDA 483 observations)
  • Postmarket support (complaints, medical device reports, field actions/recalls, mandatory problem reporting, vigilance reporting, postmarket surveillance reporting, etc.)

Learn About Our Other Services