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WBSP088:Grow Your Business by Learning Key Nuances From the Medical Device Industry w/ Tom Rodden

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Manage episode 295017418 series 2839167
Conteúdo fornecido por Sam Gupta. Todo o conteúdo do podcast, incluindo episódios, gráficos e descrições de podcast, é carregado e fornecido diretamente por Sam Gupta ou por seu parceiro de plataforma de podcast. Se você acredita que alguém está usando seu trabalho protegido por direitos autorais sem sua permissão, siga o processo descrito aqui https://pt.player.fm/legal.

Complying with regulatory bodies is more than just producing the documentation when they ask for it. If the regulatory body is as stringent as FDA, they look for several red flags, including completeness and thoroughness of the documentation and confidence level. But speed is typically the most critical factor. Manufacturers with manual processes and fragmented systems might struggle with the speed expectations of these regulatory bodies.

In today's episode, we have our guest, Tom Rodden, who discusses the nuances of medical device manufacturing and how it differs from generalized manufacturing. He also discusses several processes and system needs that are driven by regulatory bodies such as FDA. Finally, he shares several stories where poorly maintained systems and methods may have had catastrophic results for the company.

For more information on growth strategies for SMBs using ERP and digital transformation, visit our community at wbs.rocks or elevatiq.com. To ensure that you never miss an episode of the WBS podcast, subscribe on your favorite podcasting platform.

  continue reading

572 episódios

Artwork
iconCompartilhar
 
Manage episode 295017418 series 2839167
Conteúdo fornecido por Sam Gupta. Todo o conteúdo do podcast, incluindo episódios, gráficos e descrições de podcast, é carregado e fornecido diretamente por Sam Gupta ou por seu parceiro de plataforma de podcast. Se você acredita que alguém está usando seu trabalho protegido por direitos autorais sem sua permissão, siga o processo descrito aqui https://pt.player.fm/legal.

Complying with regulatory bodies is more than just producing the documentation when they ask for it. If the regulatory body is as stringent as FDA, they look for several red flags, including completeness and thoroughness of the documentation and confidence level. But speed is typically the most critical factor. Manufacturers with manual processes and fragmented systems might struggle with the speed expectations of these regulatory bodies.

In today's episode, we have our guest, Tom Rodden, who discusses the nuances of medical device manufacturing and how it differs from generalized manufacturing. He also discusses several processes and system needs that are driven by regulatory bodies such as FDA. Finally, he shares several stories where poorly maintained systems and methods may have had catastrophic results for the company.

For more information on growth strategies for SMBs using ERP and digital transformation, visit our community at wbs.rocks or elevatiq.com. To ensure that you never miss an episode of the WBS podcast, subscribe on your favorite podcasting platform.

  continue reading

572 episódios

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