Full Spectrum Software
Microsoft Certified Partner
(508) 620-6400
ISO 13485 Certified

Full Spectrum Software has been working in the medical device space since the 1990's. While we had a quality management system (QMS) in place then, we felt in 2009 it was important to achieve ISO 13485 certification. As our core practices were well defined and documented, the process was not terribly burdensome. However, in the years since achieving certification, we have been able to measure indicators of quality and through continuous feedback, we have been able to improve our company as a whole.

One thing we have been mindful of is the burden of our QMS and the impact on cost and calendar for any project. This is why our QMS allows us to tune it to the level of risk, harm and hazard of any project. Time and again, our clients have complimented us on our understanding of quality standards and regulatory standards. This helps expedite not only product development but also audits and preparation time for FDA submission.

Guidances
  • 21 CFR Part 820
  • 21 CFR Part 11 (Electronic Records)
  • 45 CFR Parts 160 (HIPAA)
  • 45 CFR Parts 162 (HIPAA)
 
  • 45 CFR Parts 164 (HIPAA)
  • ISO 14971
  • HE75 (Human Factors)
  • ISO 62366 (Human Factors)
 
  • CLIA Waivers
  • Off-the-Shelf Software
  • Product-Specific Guidances
  • ISO 13485