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Latin: a priori, pre-known + Greek: proïon, product + Tech-Term: IO, input/output
Pivotal MEDesign is well versed in the business and operating procedures of startups to fortune 500 companies
MY Success Stories
Success Stories
Abbott Laboratories
Engineering Team Size: 40 (primarily employees)
- Accomplishments: Grew a team from 0 to 40 members in 6 months to staff a 2-year program for building a multi-parameter ICU monitor that recorded:
- Arterial and venous oxygen saturation
- Thermodilution cardiac output
- Continuous cardiac output
CardioVention
Engineering Team Size: 40 (36 were outside consultants)
- Accomplishments: Delivered a heart & lung bypass machine to production in 18 months with CE and FDA approval
Triple Ring Technologies
Engineering Team Size: Grew a team from 3 to 70+ employees and 30+ consultants.
Accomplishments:
- Improved revenue from $1M to $20M
- Obtained ISO 13485
- Established processes to run development programs, still in use today
- Wrote 400+ proposals and oversaw ~60 projects
- Projects ranged from $5000 to $20M & team size from 1 – 45
- Participated in ~15 FDA submissions
Aproio & Pivotal MEDesign
Engineering Team Size: various Accomplishments:
- Medical Product Development
- Implement lean quality systems (SOPs and templates) which meet ISO 13485 and FDA design controls
- Train client team on development processes and best practices
- Guide the team:
- to meet software standards that are required for regulatory submission
- to meet ISO standards for product safety certification
