FDA's 820 CFR (QSRs)

Novem Medical proudly adheres to the FDA's 820 CFR (Quality System Regulations), a testament to our commitment to meeting and exceeding the regulatory requirements set forth by the U.S. Food and Drug Administration. This certification underscores our dedication to the highest quality standards in the medical manufacturing industry.

ISO 13485:2016

Our adherence to the FDA and ISO 13485:2016 certification is a mark of distinction in the medical device industry. This certification reflects our compliance with international quality management standards, ensuring that our processes consistently meet regulatory and customer requirements.

ISO Class 8 Cleanroom

Novem Medical operates in an ISO Class 8 Cleanroom, a controlled environment designed to minimize particulate contamination during manufacturing processes. Our 500 m² cleanroom facility ensures that the air quality and cleanliness meet the stringent standards required for the production of high-precision medical components.


At Novem Medical, our commitment to excellence is underpinned by a series of certifications that reflect our unwavering dedication to quality, compliance, and the highest industry standards.

  • Kaizen: Continuous improvement methodologies to enhance operational efficiency.

  • 7S’s: Streamlining workspace for optimal productivity and organization.

  • Standard Work: Developing and implementing standardized processes for consistency.

  • TPM (Total Productive Maintenance): Maximizing equipment effectiveness to eliminate downtime.

  • SMED (Single-Minute Exchange of Die): Minimizing setup times for increased flexibility.

  • PDCA (Plan-Do-Check-Act): A systematic approach for continuous improvement.

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ISO Clean Room Class 8

An ISO 8 clean room is a controlled environment with strict airborne particle limits for manufacturing and research in industries like electronics and pharmaceuticals to ensure high product and process quality.

ISO 13485:2016

ISO 13485:2016 is a quality management standard specifically for medical devices. It ensures that organizations in the medical industry adhere to rigorous quality and regulatory requirements throughout the entire product life cycle.


FDA, or the Food and Drug Administration, is a regulatory agency in the United States overseeing the safety and effectiveness of medical products, food, and more. It plays a crucial role in ensuring public health by setting and enforcing standards for industries under its purview

21 FDA ́s 820 CFR (QSRs)

FDA's 21 CFR Part 820, also known as Quality System Regulations (QSRs), establishes quality management standards for medical device manufacturers in the United States. It outlines requirements to ensure the safety and effectiveness of medical devices throughout their lifecycle.

Novem Medical: Where precision meets certification, ensuring excellence in every medical component we craft.
Enrique Castro
Operations Manager and Founder

Novem Medical: Precision meets certification excellence. Committed to FDA's 820 CFR, ISO 13485:2016, and operating in an ISO Class 8 Cleanroom for unparalleled quality and compliance