Introduction
BDL Consulting provide contract consulting services for New Product Introductions (NPI) in the Healthcare and Medical Device Industry. We specialise in the Product Lifecycle Process from the Product Design phase to the Manufacturing phase by offering specialised services in a multitude of sectors. From Mechanical Product Design, Quality Assurance with Design Controls, General Project Management, Validations and Manufacturing services we can help you along the development path. Please browse our website and review our services and contact us to hear how we can help you bring your products to market.
Design Controls
BDL Consulting has the unique position of having extensive knowledge of the current CE and FDA Design Control Regulatory Requirements required to release new products to market, and we combine this knowledge with our Product Design to populate the DHF in order to ensure that our customers products achieve successful regulatory approvals for market release.
Project Management
Project Management is a key aspect for the management of medical device projects. Following recognised Product Lifecycle principals and procedures is essential to getting a new Device authorised by an official body for market release. BDL consulting offer Project Management services that follow these recognised principals and we have managed many successful projects.
Commissioning, Qualifactions and Validation
All new and existing equipment involved in the manufacture and testing of medical devices must be validated prior to and during use to ensure that they remain in compliance and produce the required products in accordance with their approved design specifications. BDL Consulting has extensive international experience in the management of equipment transfers, commissioning and validations.
Manufacturing Services
BDL have extensive experience in developing products from concept to production. We have knowledge of the complete manufacturing process from Tooling to manufacturing and Quality. We have supported many manufacturing projects from equipment design, builds and installations to process development and packaging. Contact us for details.
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