Regulatory Affairs & Quality Management Services
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.
CERTIFICATIONS
OUR CAPABILITIES
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Regulatory Affairs ServicesWe 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.
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Quality Assurance ServicesRegulatory bodies require traceable processes and documentation to ensure quality, performance, safety, and effectiveness of medical devices. We have a long history of expertise 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.
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Clinical StrategyManufacturers 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.
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Authorized RepresentativeMedical 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.
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Design and Manufacturing Quality EngineeringA comprehensive risk management strategy not only supports patient and user safety but also appropriate verification and validation activities, and implementation of effective and efficient processes. We partner with your teams to implement a risk approach throughout the life cycle of your Medical Device or In Vitro Diagnostics (IVD) Device.
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Technical ExpertiseHaving 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 & QUALITY MANAGEMENT
OUR LOCATIONS
Europe
Stockholm, Sweden
Riddargatan 12A
114 35 Stockholm
Sweden
Gothenburg, Sweden
Entreprenörsstråket 10, GoCo House
43153 Mölndal
Sweden
Münich, Germany
Landsberger Strasse 302
80687 Munich
Germany
Lausanne, Switzerland
Chemin de Rovéréaz 5
1012 Lausanne
Switzerland
Olten, Switzerland
Baslerstrasse 44
4600 Olten
Switzerland
Barcelona, Spain
Ronda de Sant Pere, 16
Utopicus Building, 5th floor
08010 Barcelona
Spain
United States
San Jose, California
224 Airport Parkway, Suite 250
San Jose, California 95110
U.S.
Asia Pacific
Sydney, Australia
Glenwood, Sydney
NSW 2768
Australia
Prashanthi Enclave
Kanajiguda
Secunderabad – 500015
Telangana, India
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