At 3 HTi we understand that medical device manufacturers are facing multiple challenges in bringing their products to market.  Being fast to market with innovative products while adhering to cost demands is challenging and on top of that you need to adhere to the latest regulatory compliances.  These compliances require more cross functional needs across corporate regulatory, global supply chain, packaging, product lifecycle management, corporate quality and IT infrastructures.

We at 3 THi have the experience and tools to help your company manage the lifecycle of product data and meet the challenges of regulatory compliances:

  • Complying with FDA 21 CFR Part 11, Part 820 as well as ISO 13485 and the European MDD (2007/47/EC and 93/42/EEC)
  • Easily manage and gather all product information necessary for audit requests and regulatory submissions including the Design History File (DHF), Device Master Record (DMR) and Unique Device Identification (UDI)
  • Implement Closed Loop Quality processes to deliver a high quality, safe and reliable product, through integral CAPA, Nonconformance and Customer Complaint handling
  • Reduce risk and improve product quality and reliability by facilitating a risk-based approach to product design and validation aligned with ISO 14971
  • Maintain a central repository for important records including SOPs, Validation & Qualification documents, Risk Management documents, training records, design files, purchase specifications, test methods & procedures, DOE documentation and requirements specifications
  • Manage the proliferation of Embedded Software as well as standalone Medical Device Data Systems and implement software design controls that support CFR 21 Part 820 and IEC 62304 with solutions for Application Lifecycle Management
  • Meet compliance deadlines for RoHS and REACH guidelines with solutions for Environmental Compliance
  • Enable Design in Context in a heterogeneous environment, to Design Complex products with more variants using multiple tools