ISO 13485 Injection Molding: Micromolds Renews Certification
Updated: Sep 3
Certification underscores company’s commitment to quality management and reliable manufacturing for medical and microfluidic applications.
Precision micro injection molding company Micromolds has successfully renewed its ISO 13485 certification, reinforcing its quality management framework for ISO 13485 injection molding and medical device manufacturing.
The certification further strengthens Micromolds’ position as a trusted partner for engineering teams developing high-precision components for regulated applications, including medical devices and microfluidic systems.
“Renewing our ISO 13485 certification reflects our commitment to controlled, repeatable, and traceable manufacturing processes. It ensures that our customers can rely on consistent quality when developing products for regulated environments.” – Dominykas, CEO at Micromolds.
Commitment to Quality and Process Control
ISO 13485 is a globally recognized standard for quality management systems specific to the medical device industry. It ensures that organizations maintain strict control over production processes, documentation, and risk management.
With this recertification, Micromolds continues to practice:
Structured and validated manufacturing workflows
Full traceability across production stages
Controlled process environments
Consistent quality assurance protocols.
These capabilities are essential for customers operating in regulated industries where precision and reliability are critical.
ISO 13485 Injection Molding for Medical and Microfluidic Applications
ISO 13485 injection molding provides a controlled quality management framework for manufacturing components intended for medical and other regulated applications. At Micromolds, this framework supports our micro injection molding processes, where component geometries can reach micron-level dimensions and even minimal deviations may affect product performance.
ISO 13485 certification enables Micromolds to better support:
Medical device manufacturers
Microfluidic chip developers
Advanced diagnostics and lab-on-chip solutions.
By aligning manufacturing processes with internationally recognized standards, the company ensures a higher level of confidence for its global partners.
Strengthening Foundations for Future Growth
The renewal reinforces Micromolds’ ongoing development and supports its expansion into international markets requiring strict regulatory compliance.
The company continues to invest in:
High-precision tooling and micro-scale manufacturing technologies
Process optimization and validation
Long-term partnerships with engineering-driven organizations.
About Micromolds
Micromolds is a precision manufacturing company specializing in micro injection molding, tooling, and high-precision polymer components for medical, microfluidic, and electronics industries. Visit micromolds.eu/about-us for more information.
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