Process validation for medical devices starts well before production. We create custom validation plans, from go/no-go criteria to complete IQ/OQ/PQ validation, optimized for repeatability, traceability, and FDA and ISO 13485 compliance using scientific molding and statistical tools.
Validation, Your Way
IQ, OQ, PQ Validation
Test, Document, Trace
We apply scientific molding to optimize fill, pack, and hold stages. Our newest automation line adds real-time CpK tracking, high-res inspections, and dimensional verification for in-spec performance at scale.
We’ve invested in full-facility visibility to support your medical device process validation. Our DelmiaWorks (IQMS) ERP system is hardwired into every process, giving us real-time traceability from validation through commercial production. Our systems detect deviations from validated states and can trigger auto shutoffs to ensure in-spec production. Cleanroom environmental factors are also monitored and logged for compliance.
We develop or execute Validation Master Plans (MVP), IQ/OQ/PQ validation, and risk-based assessments tailored to your medical device and process requirements.
We run capability studies, gage R&R, and FMEA using Minitab. All measurement tools are NIST-traceable and calibrated to support compliant manufacturing process validation.
We perform First-Article Inspections (FAI) and dimensional checks using Keyence vision systems and metrology tools to confirm specs, measurement accuracy, and traceability.
At BMP Medical, medical device process validation is a team effort. Our quality, engineering, and technical leads collaborate from planning through execution. Whether you’re working from a supplied protocol or need end-to-end support, we simplify complexity and avoid rework. Each program follows a Master Validation Plan with tollgate reviews—Pre-IQ, Pre-OQ, Pre-PQ, and RTM—culminating in a Project Closeout to align outcomes.
Our collaborative mindset and technical depth help OEMs turn great ideas into manufacturable solutions.
Learn more about usOur medical device process validation services cover the full process—from Validation Master Plans and IQ/OQ/PQ protocol development to statistical analysis, FMEA, gage R&R, and traceability through DelmiaWorks. We support both customer-led and custom-built validation programs.
We apply scientific molding and statistical tools to optimize and validate the manufacturing process. Our process validation for medical devices includes capability studies (cPk, pPk), tooling verification, and dimensional inspection using vision systems and metrology.
Yes. We offer full IQ/OQ/PQ validation services as part of our medical device manufacturing process validation approach. This includes gage R&R, first article inspections, tooling verification, and Minitab-based statistical analysis—tailored to your product and regulatory requirements.