REGULATORY AFFAIRS & QUALITY MANAGEMENT

We have a successful track record of regulatory submissions for Medical Devices, In Vitro Diagnostics, Software as a Medical Device (SaMD), Drug-Delivery Systems, and Device-Led Combination Products. We work with FDA and major Notified Bodies and Competent Authorities/International Regulatory Agencies worldwide to determine the optimal regulatory pathway for your product, minimizing potential obstacles. Our approach is pragmatic and efficient, enabling you to achieve your commercial objectives quickly, while confidently meeting all necessary regulatory requirements.

Regulatory bodies require traceable processes and documentation to ensure quality, performance, safety, and effectiveness of medical devices. We have over 30 years of experience designing Quality Management Systems that align with the risk and complexity of your device, your organization's needs, and specific performance and customer requirements.

We focus on achieving consistent quality compliance while ensuring that your products meet regulatory standards and work closely with you to create a tailored Quality Management System that is efficient, effective, and scalable to support your business goals.

Manufacturers must objectively demonstrate the safety and performance of a medical device before bringing it to market. This evidence, unless duly justified, must originate from thoroughly designed and executed (pre- and post-market) clinical activities to provide evidence that the device performs as claimed. Our Clinical Research Organization (CRO) services bring decades of experience in medical device engineering, quality, and regulatory affairs, to support all aspects of your project comprehensively.

Medical device and IVD regulations often require local presence to place products on the market. With multiple global offices, Veranex helps you navigate the regulatory requirements for each, acting as your designated local representative or agent and assisting you in meeting all regulatory requirements.

A comprehensive risk management strategy is crucial for ensuring the safety of patients and users throughout the life-cycle phases of your Medical Device or In Vitro Device (IVD). We partner with your internal resources and design teams to develop a clear risk management strategy, identifying the appropriate Verification and Validation activities that demonstrate how to mitigate identified risks.

Having worked within the FDA, Notified Bodies, larger organizations, and nimble start-ups, our subject matter experts bring a wide array of specialization to each project they work on. This ensures the delivery of timely, superior project results in areas such as Software, Cybersecurity, Electrical Safety, Biocompatibility, Sterilization, and more.