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Rev.1 Engineering Achieves ISO 13485:2016 Certification

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Rev.1 Engineering has officially received the ISO 13485:2016 certification for our robust quality management system. This certification is a testament to our commitment to upholding the highest standards in the development and manufacturing of medical devices.

View our ISO 13485:2016 Certificate

What does ISO 13485:2016 mean for you?

The ISO 13485:2016 certification is widely regarded as the gold standard in our industry. It provides a structured framework that meticulously aligns medical device design, development, and production with exacting customer specifications and stringent regulatory requirements.

Equipped for Excellence: This certification supports that we’re equipped with the tools and knowledge necessary to serve our customers by staying updated with the latest regulatory requirements specific to the medical device industry.

“Acquiring the ISO 13485:2016 certification is a momentous milestone for Rev.1 Engineering. It showcases our dedication to ensuring product quality and regulatory compliance. Coupled with our in-house expertise in medical device development and manufacturing, this certification reinforces our position as the ideal partner for clients seeking excellence in product development and strategic manufacturing.”

Laura Herrera – Vice President of Quality at Rev.1 Engineering

Why ISO 13485:2016 Matters

ISO 13485:2016 signifies a commitment to quality, safety, and customer satisfaction in the medical device industry. Here’s why this certification is important for you:

  • Enhanced Quality Control: ISO 13485:2016 mandates rigorous quality control procedures throughout the entire product development and manufacturing process. This ensures that every medical device produced by Rev.1 Engineering meets the highest quality standards, safeguarding patient health and well-being.
  • Global Recognition: Our certification is internationally recognized. Companies with ISO 13485:2016 certification have a competitive edge in attracting customers worldwide.
  • Regulatory Compliance: In a highly regulated industry, this certification helps us navigate complex regulatory requirements, demonstrating our commitment to adhering to the highest levels of compliance.
  • Customer Trust: When you choose Rev.1 Engineering, you’re partnering with a company that prioritizes safety, quality, and adherence to industry best practices. You can trust us with your medical device development needs.
  • Continuous Improvement: ISO 13485:2016 requires us to maintain a culture of continuous improvement. This means we’re dedicated to finding ways to enhance our processes and deliver even better results.

About Rev.1 Engineering

Based in sunny Southern California, we’ve been a trusted partner for innovative MedTech businesses since 2007. Our comprehensive services encompass everything from conceptualization and prototype development to Early Manufacturing and beyond. .

Our achievement of the ISO 13485:2016 certification is a significant milestone in our journey towards excellence. This certification underscores our commitment to delivering safe and high-quality medical devices while ensuring compliance with the most stringent industry standards. You can confidently choose Rev.1 Engineering as your trusted partner for all your medical device development and manufacturing needs, knowing you’re aligned with a company dedicated to excellence in every aspect of our work.