Industry Perspective
Having developed software systems powering some of the most successful medical devices on the market today, the founders of Simply Good Medical Software LLC understand that software engineering expertise, and talent, as well as knowledge and experience in the pertinent business domains, industry regulations, and industry standards, are all critical success factors.
Over their 25+ years of experience, our development team members have successfully developed some of the most sophisticated products and applications to comply with medical software regulations and standards, including:
- Title 21 – CFR Part 11
- Title 21 – CFR Part 820
- Title 42 – CFR part 3 section 3.10 – 3.552
- Title 45 – CFR part 164 – 164.102 – 164.534
- ISO 13485:2003
- ISO 14971:2007
- Medical Device Directive: 90/385/EEC; 98/79/EC
We Work For You
Our team work s within clients' QMS to ensure total conformity and compliance with the related processes and procedures. We complement your team's core competencies to recover or accelerate your product’s time to market.
Our Commitment to You
At Simply Good Medical Software, we're committed to providing you with software development services that empower and free you to focus on your specific core medical product development needs.
Contact us today to explore how we can make a difference for your company.