Accelerating the Performance of Medical Device Outsourcing
Oberg Medical, an Oberg Industries Company, is a precision machining, stamping, and tooling contract manufacturing partner supporting Medical Device OEMs. We provide metal and plastic implants, instruments and assemblies, and automation solutions for a variety of Medical Device Segments with focus on the Orthopedic, Spine, Extremity, Endoscopic/ Laparoscopic, and Cardiac Rhythm Management (CRM) Markets.
Focus On Quality
ISO 13485 Certified | FDA Registered | Process Validation | Risk Management Installation Qualification (IQ) and Operational Qualification (OQ) have been completed on all equipment used in our manufacturing processes in accordance with the Global Harmonization Task Force (GHTF) guidelines. For all in-house Special Processes, we have completed/documented IQ, OQ and Process Qualifications.
In-house Validated Special Processes
- Heat Treating
- Passivation (citric/nitric)
- Abrasive Blasting
- Laser/micro-TiG Welding
- Pad Printing
- Laser Marking
We have a formal Purchasing Controls System in-place that requires evidence of process validation for any sub-supplier of "Special Processes". In addition, enhanced Risk Management and Audit Requirements are in place to ensure the supply chain is transparent and effective for all projects. We mitigate product risk by utilizing Advanced Product Quality Planning Tools (APQP) such as: PFMEAs, Control Plans, Process Flows, Gage R&R Studies, and Capability Studies as part of our Design Transfer Process for new launches and vendor consolidation/ transfer activities.