Digital Health & SaMD
We deliver hands-on trial management, SaMD development and operations, security and product quality experience, and best practice.
How we can help you succeed
Software as Medical Device, or SaMD, is new territory for many businesses performing clinical and commercial development. We recognize the importance of timely delivery aligned to trial timelines and product releases.
We help ensure that you and your team reach your goals with the right direction and high-quality deliverables in your next or current SaMD for inclusion in clinical trials or for launch. By calling on our experience and deep knowledge of SaMD development practices, standards, and regulations, we help ensure high-quality, compliant, on-time delivery of your SaMD while setting your organization up for smooth and sustainable operations.
Through better alignment and engagement management, we increase the awareness of your SaMD and the adaptability to future changes while ensuring you reap the benefits.
Explore how we can help you
Do you need to develop and validate a SaMD solution?
CHALLENGES OUR CLIENT FACE
SaMD is still new to the healthcare industry and our clients are often challenged when it comes to navigating the regulations to develop and validate a SaMD solution.
HOW WE HELP OUR CLIENTS
We support our clients to deliver and document validated SaMD solutions, aligning all development and documentation activities in accordance with external regulations and internal QMS processes. Additionally, we provide change proposals for any new process implementations that are required for the SaMD.
We start by outlining and embedding organizational processes for SaMD use. While managing the SaMD validation, we pay attention to embedded operations and maintenance processes to ensure quality and a continuously validated state of the product.
Do you need to implement processes for operating a SaMD solution in a clinical trial or in the market?
CHALLENGES OUR CLIENT FACE
Our clients experience that the operational maturity level of their SaMD solution does not meet their desired standards or expectations, risking delays for trial initiation and market launch.
HOW WE HELP OUR CLIENTS
To help our clients operate new SaMD solutions, we provide an implementation plan, instructions and guidance documents for operating and maintaining the SaMD in accordance with the relevant regulations. Upon establishing the processes, we provide continuous inputs to QMS improvements to ensure that the processes are being documented.
Alongside operation and maintenance, we provide deliverables in compliance with relevant regulations and ensure key stakeholder alignment between the departments involved in operating the SaMD solution.
Do you need to ensure regulatory compliance of your SaMD solution?
CHALLENGES OUR CLIENT FACE
The regulatory landscape for SaMD is continuously evolving, with new guidelines and requirements being introduced. Or clients are challenged navigating and understanding how the regulations apply to specific characteristics and intended use of the SaMD solution.
HOW WE HELP OUR CLIENTS
To help our clients assess the regulatory compliance of their SaMD solutions, we work closely with the client to conduct an in-depth analysis of the software. Based on the analysis of the software’s components and system architecture, we compare the findings to the relevant regulations and provide advice on how to ensure compliance.
We support activities ranging from evaluating the product against regulations, reviewing study protocols, drafting a regulatory strategy, determining data flow, analyzing software components and system architecture, and guiding and supporting all aspects of product development.
Contact Devote Consulting
We analyze each situation and identify opportunities and root causes to introduce changes into your organization with best-fit business processes and associated digital enablement, without compromising compliance. Reach out now if you are curious to learn how Devote Consulting can make a difference for you
Our Capabilities & Services
Our consulting experience spans across R&D, Clinical Operations, Pharmacovigilance, Quality, and Regulatory Affairs, with consultants specialized in individual areas and across. We bring the experience and overview that enables us to quickly understand any situation and ensure business and compliance needs are met.
