Medical Device

Is your Medical Device company accelerating time-to-market AND meeting the IT FDA compliance requirements?

Medical Device companies today are under pressure to get products to market faster in an environment of increasing FDA and other international agency compliance requirements. These regulatory pressures along with increasing product complexity, rapid globalization of the market, create an environment where quality, reliability and safety compete head-to-head with the business imperatives to reduce time-to-market and increase product development efficiency.

Medical Devices
SPK and Associates has helped Medical Device companies for over 12 years to confront and solve this dilemma. Our ALM capabilities, deep IT expertise, and thorough understanding of the FDA regulatory directives allow us to help Medical Device companies manage their product development process as efficiently as possible with a constant eye towards quality.

SPK and Associates drives your business toward operation excellence via:

  • Implementation and management of MCAD, EE, and Software Engineering applications supporting your FDA compliant design control procedure
  • Development of Traceability reporting (Requirements, Verification and Validation Testing Results, Change Control)
  • Incorporation and support of CSV procedures in IT application or infrastructure environment management
  • Product Lifecycle Management (PLM) solutions
  • MCAD/ECAD/Software Mechatronics expertise

Contact us today to learn about IT FDA requirements and compliance training best practices to help your business gain the competitive market advantage. You can also find more useful information on topics related to Computer System Validation in our blog category, CSV Computer System Validation