Standards in the MedTech Industry
Industry standards play a critical role in medical device development, guiding safety, quality, and regulatory compliance. Understanding how these standards work, and how to apply them effectively can make the difference between smooth progress and costly delays.
In this MedTechMan insight, Justin Bushko highlights why standards matter and how they support consistent, high-quality outcomes.
The Backbone of Compliance and Quality
Industry standards are the foundation of safe, compliant medical device development. Standards such as ISO 13485 and IEC 60601 guide everything from design and manufacturing to production and post-market surveillance, providing a clear benchmark for safety, quality, and performance. Understanding the purpose behind these standards and how to apply them correctly is critical for building devices that meet regulatory expectations.
Successful compliance requires coordination across teams, regular training, and clear operating procedures that translate standards into everyday practice. As standards evolve, staying current through audits, reviews, and ongoing education helps reduce variability, prevent errors, and maintain consistent quality. When industry standards are effectively integrated into processes and SOPs, compliance becomes more manageable and medical devices are better positioned for long-term success.
Justin Bushko
President, Concise Engineering
Next Steps
We hope you find this newsletter valuable and insightful.
If you have any questions, if you have feedback or would like to explore any specific topics further, please feel free to reach out to us.
Please email me at jbushko@concise-engineering.com or to book a call with me, click this link.
Stay tuned for future editions where we'll continue to share valuable information and industry updates.