Medical devices
Our team of experts serve medical device manufacturers by providing quality, regulatory, and clinical research services that cover the entire product lifecycle.
Solutions tailored to your needs
Our quality assurance (QA), regulatory affairs (RA), and clinical research experts work together to create the most efficient solutions for you. We are a multidisciplinary team with proven industry expertise and experience. Our dedicated professionals are ready to deliver results, always collaborating closely with each customer. Whether a standalone project or a long-term collaboration, we support every phase of your product lifecycle to enable you to achieve your business goals and market approval.
QA/RA services for the medical device industry
We help you manage medical device guidances, regulations, and standards. Our highly qualified QA/RA professionals have the experience and expertise to provide you with effective and tailored solutions.
Our services are customized to your needs and may include, for example:
- Regulatory strategies to adapt changes in the regulatory landscape
- Technical documentation
- Clinical evaluation or IVD performance evaluation
- Biological evaluation
- Market registrations and post market surveillance
- Risk management
- Usability engineering
- Due diligence
- Quality Management System (QMS) services
- Auditing services
- Digital health and cybersecurity
- Outsourcing of Quality Managers and PRRCs to strengthen your team
Medical device CRO services
We have the medical device expertise to help you with all aspects of your clinical investigations from planning, designing and executing through to analysis and reporting. We have extensive experience with all types of clinical investigations including first-in-human studies, feasibility or pilot studies, randomized controlled clinical investigations, and registry studies. We can also support you with your clinical evaluations, as well as partnering with you to build the right clinical development strategy for your medical device.
Our clinical investigation services include:
- Clinical operations, including feasibility assessment and site evaluation, regulatory submissions, and monitoring and site management
- Clinical project management
- Medical writing, including preparation of all necessary documentation
- Data management and biostatistics
- Vigilance
- Outsourcing services to support your team during critical phases when you need extra resources/interim solutions
- Regulatory services
Our customer-centric approach means that our client’s needs guide our focus to create impactful results.
We prioritize transparency, dependability, and delivering high-quality results.
We deliver agile, tailored solutions through deep expertise and a commitment to excellence.
Explore our services
Quality assurance & regulatory affairs services
Quality assurance (QA) and regulatory affairs (RA) services covering the entire lifecycle of your medical devices and in vitro diagnostic medical devices.
Medical device & IVD CRO services
Full-service clinical research services for medical devices and in vitro diagnostic medical devices.