Navigating Regulatory & Quality with Agility & Care
Veranex provides tailored regulatory and quality solutions for medical device companies. Whether you’re launching a new product or need support for an existing device, our experienced team will ensure your success.
What we offer
Our approach is centered around understanding your strategy and business needs. With a global team that possesses extensive industry-wide expertise, we are an integral partner in defining efficient and effective strategic pathways to commercialization.
We recognize the importance of integrating with your working culture and adhering to your professional standards. Our commitment to offering scalable, knowledgeable, and flexible services ensures that we can adapt to your changing needs at every stage of product development.
Whether you’re at the project ideation phase, seeking initial certification and/or regulatory clearance/approval, or looking to expand your indications, we offer fully customized solutions designed to help you bring innovative products to market while ensuring compliance with all applicable regulatory requirements and quality standards.
We recognize that every organization is unique, and we strive to provide consultative support that meets and exceeds your expectations.
Regulatory Affairs Services
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.
Quality Assurance Services
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. Working closely with you, we create a tailored Quality Management System that is efficient, effective, and scalable to support your evolving business goals.
Manufacturers must objectively demonstrate the safety and performance of a medical device before bringing them 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. Veranex’s CRO (Clinical Research Organization) 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 offices in multiple geographies, 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.
Design Manufacturing and Quality Engineering
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 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.
Our subject matter experts bring a wide array of specialization, having worked within FDA, Notified Bodies, larger strategic organizations, and nimble start-ups. This extensive product exposure and up-to-date technical knowledge ensure the delivery of timely, superior project results in critical areas such as Software, Cybersecurity, Electrical Safety, Biocompatibility, Sterilization, etc. You can trust Veranex for expert guidance and successful outcomes across all these curtail areas.
We support diverse MedTech specialties, including Medical Devices, IVD Devices, Drug-delivery, Digital Health, Biologics and Precision Medicine. Our solutions cater to all company sizes, from university spinouts and start-ups to mid-size organizations and multi-national corporations.
Integrated service offering
Veranex is an integrated solution provider that offers a comprehensive range of services to meet all your MedTech needs. In addition to our Regulatory and Quality Services team, our Product Development & Engineering, Clinical Investigation, and Commercial Strategy and Market Access teams can work in concert to implement a plan that accelerates your business objectives and reduces your time to market.
REGULATORY AFFAIRS &
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