Episode 027: Harsh Thakkar (@harshvthakkar) interviews Niyati Patel (@niyatipatel), the Director of Quality Engineering at Getinge (Maquet Cardiovascular) and a Sr. Regulatory/ Quality Consultant at Compliance Insight, Inc.

Niyati breaks down the complexities of quality management systems, compliance, and regulations in the industry. She discusses the unique challenges companies face, especially when dealing with drugs, devices, and combination products, and emphasizes the importance of expert consultation and the use of technology in achieving compliance.

Harsh and Niyati debate the differences between a QMS and a BMS and the strengths of each. They elaborate on how a robust QMS acts as the backbone of a company's compliance strategy, integrating various processes and ensuring they are up to par with regulatory standards.

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Links:

*Compliance Insight, Inc.
*Compliance Insight, Inc. LinkedIn
*Getinge
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Show Notes:

(6:56) Integrating BMS and QMS in various industries.

(11:31) Regulations for combination products and their unique challenges.

(19:24) Drug and device regulations for small startups.

(24:56) Software selection for biotech companies.

For transcripts, check out the podcast website - www.lifesciencespod.com