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Medical Device Validation Services

Whether you’re launching a new device or updating an existing line, we provide full medical device process validation. We offer IQ/OQ/PQ validation, capability studies, gage R&R, vision inspection, and metrology, with data-driven, audit-ready documentation tailored to your product.
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From First Shot to Full Approval

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

We support customer-owned or co-developed protocols for flexible medical device validation services that meet your regulatory, technical, and operational goals.

IQ, OQ, PQ Validation

Gage R&R, cPK/pPK studies, and tooling verification backed by statistical rigor—aligned with ISO 13485 and 21 CFR 820 for risk-based audit readiness.

Test, Document, Trace

From inspection with Keyence systems to ERP-backed documentation in DelmiaWorks, we deliver full traceability and dimensional accuracy at every stage.
Close-up of an injection molding machine with control panel and exposed mold plate.
Digital measurement system displaying a 3D scan and dimensional analysis of a component on a connected monitor.

Built on Scientific Molding & Repeatability

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.

Systems That Support 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.

Generate the Data

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.

Inspect and Verify

We perform First-Article Inspections (FAI) and dimensional checks using Keyence vision systems and metrology tools to confirm specs, measurement accuracy, and traceability.

Document and Trace
All activity is logged in our EDMS and ERP, with traceable records and audit trails maintained per ALCOA+ data integrity to meet ISO 13485 and FDA 21 CFR 820 standards.

Validation is a Shared Responsibility

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.

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Our Approach

We’re more than a supplier—we’re a strategic partner. As a family-owned company, we move fast, stay flexible, and invest in what matters.

Our collaborative mindset and technical depth help OEMs turn great ideas into manufacturable solutions.

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Looking for a partner you can count on?

We help OEMs bring complex molded components to life—with the care, speed, and flexibility they depend on.
  • “They make us feel like we’re their only customer. Their responsiveness and willingness to work through challenges make them a great partner.”

    Pharmaceutical packaging customer

  • “We’ve been working together for close to 30 years. That relationship has lasted because they are responsive, supply what we need, and we trust their expertise.”

    Medical custom molded closures customer

  • “I see BMP as a partner, not just a vendor. I want a supplier that actively looks for ways to bring costs down while maintaining quality, and BMP does that.”

    In-vitro diagnostics (IVD) & specimen collection and transport customer

  • “We were trying to develop a new part, and BMP worked with us every step of the way. Their ability to customize and refine designs helped us bring it to market faster.”

    In-vitro diagnostics (IVD) & specimen collection and transport customer

  • “Unlike most molders, BMP doesn’t just take orders and quote jobs—they invest with us. We buy tools, they buy machines. We’re in it together.”

    Medical custom molded closures customer

Read Our Success Stories

Frequently Asked Questions

Our 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.