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Compliant Hosting Solutions

Medical Device

Design History File Preparation

Medical DevicesByteGrid provides Regulatory Consulting services to Medical Device and In-Vitro Diagnostic manufacturers. Preparing the necessary documentation for FDA device approval is a complicated process that requires real experience. Our team can prepare and submit the necessary documentation required to achieve EU Medical Device Directive & FDA Medical Device Classification, Pre-Market Approval (PMA), and Pre-Market equivalence 510(K) approval.

We are truly the only end to end Medical Device Compliance Services Provider. We can provide DHF support services from User Needs through Production Transfer and Submission. ByteGrid associates have assisted our customers in the Design, Test and Launch of Class I, II, III Devices, CE and IVD products. With our US & EU based teams we are the natural choice for the Global Medical Device developer.

PMA, 510(K) DHF Preparation

When it comes to Cloud integrated medical Devices, our experienced Regulatory Compliance team can provide document writing, submission assistance and regulatory strategy to ensure that your submission process is as smooth as possible.

V&V Solutions

  • Design Verification: Our experienced team can provide verification strategies for the simplest to the most complex device. We are experts in defining unambiguous and testable acceptance criteria and ensuring valid statistical techniques are employed.
  • Design Validation: We can construct clinical validation protocols that emulate real world scenarios ensuring that your trial is robust and your data complete.
  • Process Validation: By ensuring a robust and compliant manufacturing process, we can help our clients repeatedly produce high quality products time and time again.
  • Software Compliance: Does your QA headcount need a temporary boost? The ByteGrid team can act as QA document review for projects or individual systems.

GxP Training Sessions

We can provide your team with comprehensive GxP Training to ensure that they are versed in current testing practice and regulatory expectations.

COTS Validation

Our team can provide validation services for all of the software tools engaged in the development and manufacture of your device. We are staffed with an ISACA certified quality team (CISAs and CRISCs) with over 25 years combined Life Science experience. Our state of the art GxP Qualified Data Center can host all of your applications and development data in a secure, redundant and high availability environment. Ensuring that critical research data is always a click away. Located minutes from FDA in Rockville our US DC has achieved 99% uptime for the last 10 years.

  • Infrastructure: US/EU Qualified
  • Comprehensive Quality System
  • Four-tiered Physical Access Security
  • Powerware 9350 500 KVA UPS
  • Redundant and Diverse Fiber Routes
  • Dedicated 2000A Electrical Power Feed – Hospital Grid
  • Kohler 380k VA Industrial Diesel Generator
  • 60T Redundant Integrated HVAC System
  • 610Mb/s Capacity of Connectivity

Design Control Support

  • Design & Development Plan
  • Risk Management Plan
  • Configuration Management Plan
  • User Needs
  • System Requirements
  • System Design Specification
  • Software Hazard Analysis
  • System Risk Assessment
  • Software Architecture
  • Design Verification
  • Design Validation

Our Promise

ByteGrid partners will benefit from a cooperative model that balances our customer needs with risk based regulatory solutions. We provide a proven compliance approach that significantly reduces regulatory costs and most importantly, allows client funding and resources to remain focused on their Research & Development, Trials, Registration and Transfer.

Our Promise

For more information on Medical Device, please contact us or call 855.495.0098.

 

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