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Validation Engineering

Meet FDA regulations and ISO, IEC, AAMI, and other industry standards and regulations

At Shoolin, we specialize and are well known for the software and hardware development, validation, verification, and compliance engineering for medical devices. In order to meet FDA regulations and ISO, IEC, AAMI, and other industry standards and regulations, device designs must be documented and tested. Our engineering services are process driven and are specifically designed to serve the needs of the medical device design industry.

Our involvement in the initial stages of development, best assists clients by ensuring that all stages of the design and development process are adequately documented and compliant with regulations, guidance documents and standards. Early involvement is key in keeping costs under control by doing it right the first time. Unfortunately, clients sometimes come to Shoolin later in the lifecycle when the development process has already been started and the client finds that the design history file has not been properly maintained. In these cases, we can offer compliance gap analysis and remediation services to put a project back into compliance.

Shoolin’s engineers are experienced with verification and validation planning, test procedure development for unit level, integration and system testing. Shoolin is also very accomplished at developing test fixtures used to verify the device’s software, hardware and interfaces, or for QC checks during production.

Verification and validation services:

Full V&V Partner

Shoolin can partner with your design engineering team to verify and validate the device design as a critical part of the development process. This provides assurance that the design process has been planned, is progressing according to plan and the product is being designed meets the needs of your stakeholders.

Experienced engineering partner for focused V&V needs

Shoolin can support specific client needs, when an immediate experienced resource need arises. Shoolin ramps up quickly using the client’s current quality system and procedures, or substituting Shoolin’s tried and true processes and procedures to provide a road map to address specific project needs.

Compliance or remediation projects

Because of Shoolin’s experience level working with regulators and industry experts, Shoolin understands the sense of urgency necessary to address compliance and field issues. Shoolins experienced resources can define what is necessary to provide V&V and other engineering services to identify the root causes of issues and support their resolution. Naturally this is all completed with the documentation necessary to provide the required “objective evidence”. In a more proactive model, Shoolin has experience in identifying and filling gaps in compliance with regulations, guidance documents, and standards (both domestic and international).

Shoolin Engineering can:

  • Develop verification and validation(V&V) processes for your Quality System
  • Develop project verification and validation plans that define activities throughout the product life-cycle
  • Develop and/or review verification and validation inputs for completeness, accuracy, consistency, lack of ambiguity, and … testability
  • Integrate standard compliance into the product and process through a defined plan
  • Design and Develop V&V test designs and procedures that build confidence in the software and the device
  • Coordinate and execute the V&V testing process using productivity tools for configuration management and issue tracking

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