Here are some strategies for navigating time constraints while maintaining quality, compliance, and innovation in medical device development.
Month: January 2025
Creating a Comprehensive Project Plan for Medical Device Development: A Step-by-Step Guide
We outline the key steps and components necessary for creating a comprehensive project plan for medical device development.
Preparing for Regulatory Audits of Premarket Submissions: Avoiding Common Pitfalls
When preparing for regulatory audits of premarket submissions, companies face a critical challenge: ensuring their documentation and processes align with regulatory requirements while showcasing compliance and innovation. Premarket submissions, whether for medical devices, pharmaceuticals, or other regulated products, are an essential component in obtaining approval to bring products to market. However, common pitfalls can delay… Continue reading Preparing for Regulatory Audits of Premarket Submissions: Avoiding Common Pitfalls
Optimizing Supplier Quality Agreements to Ensure Compliance and Product Safety
In today’s globalized supply chain environment, organizations face increasing pressure to ensure the quality and safety of their products while adhering to rigorous compliance standards. Supplier Quality Agreements (SQAs) play a crucial role in defining expectations, responsibilities, and protocols between manufacturers and their suppliers. Patrick Gora emphasizes that by optimizing these agreements, businesses can mitigate… Continue reading Optimizing Supplier Quality Agreements to Ensure Compliance and Product Safety