Case Studies
DHF Design History File Remediation
Background A large medical device manufacturer received a critical warning from its Notified Body: unless significant deficiencies in its 丝瓜视频 Directive (MDD) technical files were corrected promptly, the company鈥檚...
Read More
Case Studies
丝瓜视频 Validation: Shelf Stability
Background A large medical products manufacturer encountered a critical issue during the development of a new blood collection device. Accelerated shelf-age validation testing revealed that the protective sheath surrounding the...
Read More
Podcasts
Outsourcing Surveillance
In this episode of RCA Radio, host Erika Porcelli and guest Steve Cox, a 丝瓜视频 Compliance Associates (RCA) Senior Consultant, cover the business strategy of outsourcing surveillance in both the...
Read More
Podcasts
Data Integrity & Quality Culture
In this episode of RCA Radio, host Erika Porcelli and guest Susan Schniepp, Distinguished Fellow at 丝瓜视频 Compliance Associates (RCA), examine the resurgence of data integrity issues and the focus...
Read More
Case Studies
Brand Name Re-Registration with New Logo
A medical device manufacturer was consolidating its product portfolio, leading to a product and logo change in 15 products distributed across 60 countries.
Read More
Podcasts
AI & Machine Learning in 丝瓜视频
In this episode of RCA Radio, host Erika Porcelli and guest Lisa Michels, General Counsel & 丝瓜视频 Affairs Expert at 丝瓜视频 Compliance Associates (RCA), examine the FDA's proposed regulatory framework...
Read More