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
We prioritize understanding your business needs so that we can effectively leverage our industry-wide expertise and be an integral partner in finding efficient and effective pathways to commercialization.
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.
Integrating into your working culture is important to us. Our commitment to offering scalable, knowledgeable, and flexible services ensures that we can adapt to your changing needs at each stage of the process.
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 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.
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 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.
Industries We Support
We operate within diverse MedTech specialties including Medical Devices, In Vitro Devices (IVD), Drug Delivery, Digital Health, Biologics, and Precision Medicine. Our solutions cater to all company sizes, from university spin-outs and start-ups, to mid-sized organizations, and multi-national corporations.
Integrated Service Offerings
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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