Post-Launch Change Requirements

Developing web-based tools, initially focused on USFDA, which will enable life cycle management of devices, indicating when a significant change or like-for-like change is likely to be applicable, and giving advice and guidance on what steps and regulatory requirements to proceed with.

Inefficient and inconsistent

  • Defining ‘like for like’ supplier change ​is unclear
  • Hard to assess how substantial a change is
  • New Regulations (e.g., EU MDR 117) and compliance of suppliers in question
  • Inefficient and inconsistent processing change evaluations linked with how regulatory reporting requirements are decided​
  • Difficulties in providing suppliers and CMO’s with clear expectations, timelines and required information
  • To enable decision-making process and allow all stakeholders to weigh up and consider all options: influencing long/short-term plans​
  • Including P-LCR consideration within the development of a Quality Agreement
  • Ensuring appropriate resources are aligned with the process

Harmonized processes

  • Standardize and streamline the P-LC process, with optimization of administrative tasks​
  • Align the process of working with suppliers, reducing reliance on individual personnel​
  • Time and resources saved
  • Comprehensive check-list, especially useful for onboarding and training
  • Increased innovation of existing products within the industry​
  • Ensure future production capability​
  • Sustainability improvements and considering raw materials used

Post-Launch Change Requirements deliverables

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