MedTech & SaMD
We support you in shaping tomorrow’s healthcare.
At Devote Consulting, we bring extensive expertise in MedTech and Software as Medical Device (SaMD) solutions to ensure your products are safe, effective, and compliant with evolving regulations. Our goal is to help you navigate the complexities of this rapidly advancing field.
THE FUTURE OF HEALTHCARE
As the healthcare industry increasingly integrates digital health technologies, SaMD is becoming a key component in clinical trials and commercial healthcare products. With this innovation comes the challenge of aligning development, documentation, and regulatory requirements along with various needed engineering and development disciplines.
By partnering with us, you will be supported in navigating regulations, engineering capabilities, and the development and operation of these products. Our commitment to excellence ensures that your solutions are built for success, from development to deployment, regardless of the make-buy split for the solution (internal, external or mixed).
ARE YOU READY?
At Devote Consulting, we combine our deep industry knowledge and technical expertise to help you thrive in the fast-paced world of MedTech and SaMD.
Unlock the full potential of your Medtech & SaMD projects with our expertise in MDR, industry standards and regulations (e.g. ISO13485, ISO 14971, IEC 62304, IEC 82304, ISO 27001), systems engineering best practices, compliance, and technology integrations. We bring the team to execute your projects effectively. Leveraging our knowledge of product engineering, design control, and regulatory strategy we drive your products forward and enhance their impact.
WE UNDERSTAND THE WORLD OF ISO13485, MEDICAL DEVICES & SaMD
We help streamline your SaMD’s lifecycle, from concept and design to validation, regulatory submission, and market launch. Whether you’re incorporating SaMD into clinical trials or preparing for product release, our hands-on experience ensures timely, high-quality results that align with your business goals.
MEDICAL DEVICE REGULATIONS
INTENDED USE
DESIGN & DEVELOPMENT
VERIFICATION, VALIDATION & REGULATORY APPROVAL
PRODUCTION, DEPLOYMENT & MAINTENANCE
Software distribution, configuration management, updates, and cybersecurity patches, as well as continuous post-market monitoring for performance, bugs, and risks. We have extensive operational knowledge of DevOps and maintenance of SaMD.
WE ARE A TRUSTED ADVISOR FOR COMPANIES OF ALL SIZES
Get in Touch
We’re here to help you implement the processes and solutions you need to grow and succeed. Unlock the full potential of your biotech company by leveraging our expertise in IT strategy, operations, data and digital enablement.
HOW WE CAN HELP YOU SUCCEED
WE HELP YOU TRANSFORM THE HEALTHCARE OF TOMORROW
IS YOUR ORGANIZATION NEW TO SAMD & DIGITAL HEALTH PRODUCTS?
Many companies, particularly those in traditional pharma or non-device sectors, face significant hurdles when venturing into the development of SaMD & Digital Health products. Without an established Quality Management System (QMS) tailored to these types of products, organizations often struggle with compliance, risk management, and product validation, leading to costly delays and regulatory setbacks or difficult situations with development partners. We specialize in helping companies transition into SaMD & Digital Health product development, whether they’re moving beyond drug therapeutics or entering this space for the first time.
IS THE PRODUCT VALIDATED & READY FOR CLINICAL EVALUTION & TRIALS?
Many face difficulties navigating the regulatory landscape when developing and validating SaMD & Digital Health products. This can cause downstream impacts to the timelines of clinical trials. We help guide your product development and validation processes, ensuring alignment with both external regulations and internal quality management systems (QMS). Our services include outlining organizational processes for product integration, life-cycle needs of almost any nature, ensuring compliance with regulations, removing surprises, and embedding operations that support long-term success.
DO YOU HAVE A TEAM TO HANDLE SAMD OPERATIONS & MAINTENANCE?
It’s essential to have a strong operational setup when deploying SaMD in clinical trials or launching in the market. We design comprehensive implementation plans and provide detailed guidance for the ongoing operation and maintenance of your SaMD solution. This ensures that your SaMD operates seamlessly in compliance with relevant regulations. Additionally, we support continuous improvement within your QMS, helping you scale efficiently as your product matures.
IS YOUR SAMD PRODUCT IN COMPLIANCE WITH LATEST REGULATIONS?
The SaMD regulations are continuously evolving, making it difficult for companies to remain compliant without expert guidance. We work closely with you to conduct detailed analyses of your SaMD solution, from its system architecture to specific software components – even if the product is owned by a partner. Our team helps you navigate the regulatory landscape, providing tailored advice on ensuring compliance with current guidelines. Whether you need a regulatory strategy, study protocol reviews, or in-depth product evaluations, we are here to ensure your SaMD product meets all necessary requirements.
DO YOU HAVE A QMS IN PLACE FOR SAMD & MEDTECH PRODUCTS?
Without an established and mature Quality Management System (QMS), organizations often struggle with compliance, risk management, and product validation, leading to costly delays and regulatory setbacks. We specialize in SaMD & MedTech product development, including the regulations and the digital enablement to control and govern the data and processes. Our team develops a robust, compliant QMS from scratch or helps mature the one you have started, aligned with international standards like ISO 13485.
ARE YOU A START-UP DEVELOPING SaMD & MEDTECH PRODUCTS?
As SaMD & MedTech companies achieve success, scalability becomes essential. We specialize in helping growing companies optimize and scale their development and operations to meet the demands of a rapidly evolving market. Whether you’re navigating clinical validation, regulatory compliance, improving data management, or just getting started with your product development, our expertise ensures that every aspect of your development process is streamlined, compliant, and positioned for growth. Ready to take the next step? Explore how we can help you scale effectively, just like we do for our pharma and biotech clients.
Meet DEvote ConsulTing
Once an entrepreneur, always an entrepreneur! We understand the perspective of starting up something new and growing a company from early stages to managing operations. We are here to be your partner in getting your company ready to bring SaMD and Medtech products to market!