MedTech & SaMD
We support you in shaping tomorrow’s healthcare.
At Devote Consulting, we bring extensive expertise in Software as a Medical Device (SaMD) and MedTech 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, ensuring your solutions meet both clinical and commercial demands.
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.
By partnering with us, you will be supported in navigating regulations, so you can focus on shaping the health care of tomorrow. Our commitment to excellence ensures that your solutions are built for success, from development to deployment.
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, ISO13485, ISO 14971, IEC 62304, systems engineering best practices, compliance and technology integrations. We bring the team to execute your projects effectively. Leveraging our deep 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.
WE ARE A TRUSTED ADVISOR FOR COMPANIES OF ALL SIZES
MEDICAL DEVICE REGULATIONS
INTENDED USE
DESIGN & DEVELOPMENT
VALIDATION & REGULATORY APPROVAL
PRODUCTION, DEPLOYMENT & MAINTENANCE
For SaMD, software distribution, updates, and cybersecurity patches incl. continuous post-market monitoring for performance, bugs, and risks.
HOW WE CAN HELP YOU SUCCEED
WE HELP YOU TRANSFORM THE HEALTHCARE OF TOMORROW
IS YOUR ORGANIZATION NEW TO SAMD & MEDTECH PRODUCTS?
Many companies, particularly those in traditional pharma or non-device sectors, face significant hurdles when venturing into the development of SaMD & MedTech 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. We specialize in helping companies transition into SaMD & MedTech product development, whether they’re moving beyond drug therapeutics or entering this space for the first time.
IS YOUR PRODUCT VALIDATED & READY FOR CLINICAL EVALUTION & TRIALS?
Many face difficulties navigating the regulatory landscape when developing and validating SaMD & Medtech products, and 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, ensuring compliant validation, 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 regulatory landscape for SaMD is 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. 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 porduct 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, aligned with international standards like ISO 13485,
ARE YOU A START-UP DEVELOPING MEDTECH & SAMD PRODUCTS?
As SaMD & MedTech companies achieve success, scalability becomes essential. We specialize in helping growing companies optimize and scale their operations to meet the demands of a rapidly evolving market. Whether you’re navigating clinical validation, regulatory compliance, or improving data management, 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 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!