What certifications does an EMS partner need for medical devices?

ISO 13485 is the core certification. Additionally, IPC certifications (A-610, J-STD-001), ISO 9001 and depending on requirements further standards are relevant.

What distinguishes medical device PCBA from standard PCBA?

Stricter quality requirements (IPC Class 3), complete traceability, validated processes, risk management and comprehensive documentation.

Medical Device PCBA

PCBA manufacturing for medical devices: learn about the special requirements for quality, traceability and certifications.

What is Medical Device PCBA?

Medical device PCBA encompasses the manufacturing of electronic assemblies for medical equipment under the strictest quality and regulatory requirements.

PCBA manufacturing for medical products is subject to particularly stringent requirements: ISO 13485-certified quality management, IPC-A-610 Class 3, complete traceability, validated manufacturing processes and documented risk management processes per ISO 14971.

Requirements and Specifics

SMTEC specializes in manufacturing medical device assemblies and holds all necessary certifications. The combination of state-of-the-art manufacturing technology, experienced personnel and a robust QMS makes SMTEC a reliable partner for medical device manufacturers worldwide.