News & Blog

Effective Risk Management For Medical Devices

Risk Management is your system of management policies, procedures, analysis practices, and monitoring risk.  An effective risk management program is an essential element in the life cycle of a medical device.     A Hazard is a potential source of harm.  A Risk is your...

How Poor Compliance Impacts Your Bottom Line

Written By: Akshaya Mohan, Regulatory Affairs Manager, PSC Biotech®Life science companies need to comply with laws, regulations, and Agency guidance.  Compliance requires understanding processes and technologies and ensuring that quality is built into your process and...

FDA Combination Products Q&A

Written By: Jorge Sugranes, Regional Director of Latin America, PSC BiotechHere are some Q&A regarding combination products (CP) that you might like. I found this information, published by the FDA*, very helpful, educational, and clarifies common questions about...


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