We stay up to date with all relevant global regulations, and research country and state-specific ones as required by your product. This guarantees your product complies with all regulations and avoids delays in approval, costly remediations, recalls and safety issues.
Our process places an emphasis on collaboration, both between ourselves and with our clients. We don’t just get your products across the finish line on time, we make sure it’s the best possible version of your product too.
Each increment produces a useable product and set of deliverables needed for the next milestone in development. Since clear objectives are defined upfront and constant feedback is provided during execution, the risk of delivery is significantly reduced.
We execute in increments defined upfront so we can demonstrate progress, validate assumptions, obtain feedback and allow time for refinement before the product is too far along. The increment approach promotes focused development which is clearly defined and allows for flexibility as the future needs become clearer.
Once the team is defined, we hold collaborative deep dive sessions jointly with your team to share and refine the objectives, strategy, technological approaches and associated risks. Together we define our short-term goals and success criteria. We believe working together increases success by building trust, increasing visibility, leveraging each other’s strengths, fostering creatively and promoting progress.
We define the technology, tools and the team as part of the strategy. Once we agree on a set strategy for the next phase of the program, we create a custom team of experts and select tools utilizing your existing framework while considering your long-term staffing plans. We believe the right team is a mix, utilizing our domain and software expertise, your existing strengths and skillsets and leveraging tools that are best suited for the product.
Once the initial assessment is complete, we will create a detailed strategy with clear deliverables, activities and product functionality that supports your next milestone while still achieving your final delivery. This strategy provides the framework for the program and helps establish the team and their long-term understanding of the product journey. This enables the team to drive the short-term objectives and make sound technical decisions without jeopardizing the subsequent milestones.
Before we embark on a new a project with you and as a continuous part of our process, we work with your team to conduct a thorough assessment covering various aspects of the program and product. This assessment is used to identify the needs, gaps, risks and opportunities that are critical for the success of the company. You cannot define a path to your destination without honestly knowing where you are today.
Whitepaper: The Rapid Rise of Digital Health Technology: Challenges and Keys to Success
Feb 16th, 2024
The Rapid Rise of Digital Health Technology: Challenges and Keys to Success Digital health merges digital technologies with health, healthcare, living, and society to enhance the efficiency of healthcare delivery to make medicine more personalized and precise. This whitepaper written in conjunction with the experts at Jama Software covers the following topics: The difference between […]
Whitepaper: How to Clear a Software Medical Device with the FDA
Jun 11th, 2023
How to Clear a Software Medical Device with the FDA This whitepaper discusses the standards and requirements needed for a successful FDA submission and clearance for a software medical device, and also defines pre-market v.s. post-market activities, submission timelines, CFR, XGMP, QMS, and DHF. It provides resources for businesses that help to ensure regulatory compliance […]
Quality / Compliance / Regulatory Updates – 3 June 2022
Jun 8th, 2022
FDA / EU / Regulatory Updates FDA releases draft guidance “Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program” This draft guidance describes the FDA’s policy about its participation in the Voluntary Improvement Program (VIP). The VIP is a voluntary program facilitated through the Medical Device Innovation Consortium (MDIC) […]
Every business is different, and we adjust our approach to suit your market-specific and team-specific needs. The way we deliver our services may differ on a case by case basis, but our commitment to our clients remains consistent.