← Regulatory Affairs & Quality Management

Regulatory Affairs
Expertise

Obtaining regulatory clearance or approval is essential for Medical Devices and In-Vitro Diagnostic Devices to enter and thrive in the market. At Veranex, our experts work with you to design and implement a customized, cost-effective strategy that ensures timely and efficient regulatory compliance, giving you foresight and control of your regulatory roadmap.

Designing for compliance

For every new development, it is paramount to identify upfront the set of applicable regulations, guidelines, processes and technical standards that apply to your product.

Throughout the entire product development journey, we provide training, coaching and hands-on support in the interpretation, implementation and documentation of the applicable requirements for design control, risk management, product verification and validation, transfer to manufacturing and Clinical/Performance Evaluation. We help you ensuring that the resulting technical documentation fulfils the expectations of regulatory bodies for further submission.

U.S. FDA

We facilitate early FDA interactions and guide appropriate regulatory pathway and program assessments (510(k), De Novo, PMA, Breakthrough, etc.) for efficient and successful outcomes.

Our team works closely with all divisions within FDA’s Center for Devices and Radiological Health (CDRH), Office of Combination Products (OCP), and Office of the Center Director.

EU MDR / EU IVDR

With evolving risk qualification and classification rules due to EU MDR & EU IVDR, increasing expectations set by Notified Bodies and challenging timelines to comply, companies must be proactive on their road to compliance.

For new products, our approach usually begins with conducting a regulatory pathway analysis. Our report covers topics such as identifying regulatory boundaries, evaluating potential borderline challenges, and determining the risk class of the product.

Once a precise set of regulatory objectives is established, we assist in selecting a qualified Notified Body and support the relationship throughout the entire regulatory process.

For legacy products, an in-depth review of your technical documentation performed through the lens of our massive experience with Notified Bodies’ current expectations allows for a proactive identification of gaps.

Global Regulatory Services

We offer support to clients in developing market entry strategies for multiple geographies, with local teams that ensure regulatory compliance. This expertise includes work with regulatory authorities such as Health Canada, TGA (Australia), ANMAT (Argentina), ANVISA (Brazil), and PMDA (Japan).

Leveraging our extensive experience, we help clients navigate individual country submissions, as well as develop a single, efficient regulatory strategy roadmap that incorporates the requirements of different regulatory authorities, minimizing time and maximizing resource efficiency.  

How does it feel to work with the Veranex Regulatory Service Team?

Veranex’s unique combination of regulatory expertise, domain know-how, and extensive experience collaborating with FDA and other regulatory bodies enables us to identify potential pitfalls and proactively mitigate project risks. This hard-earned knowledge allows us to define the right strategy at each relevant stage of the company and project’s lifecycle.

We provide comprehensive regulatory assessments, including outlining the classification/s specific to your device’s intended use and indication for use, clinical and non-clinical testing considerations, and recommended engagements with regulatory authorities.

Whether you need to complement your internal team’s skills or seek a full-service regulatory team to lead your project, our specialists will tailor our support accordingly.

With expert teams worldwide, Veranex is a proven asset to our clients, helping to build your initial submission or repair any unsuccessful submission attempts.

Regulatory Affairs Services & Capabilities:

  • FDA
    • US Regulatory Strategies
    • Q-Submissions (Pre-Submission, Submission Issue Requests, Informational Meetings, etc.)
    • Premarket Notification (510(k))
    • De Novo Applications
    • Safer Technologies Program (STeP) Applications
    • Breakthrough Device Designation Applications
    • Pre-Market Approval (PMA)
    • Investigational Device Exemptions (IDE)
    • Humanitarian Use Device/Humanitarian Device Exemption
    • Emergency Use Authorization
    • Field Actions and Recall Advisory Support
    • Labeling
  • CE-Marking
    • Product qualification and classification
    • Identification and interpretation of applicable guidelines and (harmonized) standards
    • Setup of documentation architecture and prototyping of required documents
    • Implementation of risk management process
    • Design control and V&V supporting documentation
    • Design transfer and process controls, including supplier audits
    • Clinical/Performance Evaluation and design of Clinical Investigations (pre-/post-market)
  • MDR and IVDR Transition
    • Substantiating new risk classification
    • Technical Documentation Assessment
    • Consolidation of Verification & Validation (V&V), Risk Management and Usability
    • Updating CEP and CER (MDR); PEP and PER (IVDR)
    • Defining adequate PMS and PMCF plans
  • Global Regulatory Services
    • Global regulatory strategies
    • Change notice assessment
    • External standards
    • Health Canada license support and 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
    • Vigilance/incident event reporting