PINpoint MES Technology for
Medical Device Manufacture

Name: PINpoint MES for Medical Device Manufacturing
Brand: PINpoint

Ensure regulatory compliance, process accuracy, and full device traceability with PINpoint MES – designed for manufacturing in highly-regulated environments.

MES Built for Compliance-Driven Manufacturing

Medical device manufacturing requires precision, traceability, and full regulatory compliance. But paper-based systems and tribal knowledge leave too much room for error.

PINpoint MES provides manufacturers with the digital backbone needed to comply with FDA 21 CFR Part 820, ISO 13485, and other global standards—while improving product quality and process visibility

Challenges PINpoint was designed to solve

Missing or incomplete Device History Records (DHR)
High cost of compliance audits
Manual quality checks and documentation errors
Operator training gaps and variability
Inconsistent enforcement of procedures

Built for Regulated Assembly Environments

PINpoint is trusted by manufacturers of medical devices and equipment. Our MES is designed from the ground up to provide the features and datasets needed for building products in highly-regulated industries with stringent quality controls.

How PINpoint Helps:

Digital work instructions with enforced execution and version control
Electronic records of operators, tools, parts, and inspections (eDHR)
Real-time alerts for deviations or skipped steps
Automatic collection of process data and signatures
Configurable workflows to match SOPs and regulatory needs

Here’s How PINpoint MES Supports Medical Device Manufacturing

Complete
Control

Dynamic process enforcement to prevent errors and ensure standard work compliance

Quality
Assurance

Real-time alerts and automatic corrective workflows for quality control

Automated
Traceability

End-to-end digital traceability for audits, recalls, and process improvement

Real-Time
Connectivity

Smart Tooling and IoT integration for task validation and torque checks

Digital
Work Instructions

Operator Guidance with embedded visual aids and step-by-step instructions

Day One
Results

Cloud-ready, modular architecture for fast rollout across plants and lines

Configurable, Scalable, and Fast to Deploy

Built on a modular, low-code architecture, PINpoint MES can be configured to your specific workflows and terminology used in your industry. Our experienced implementation team helps you get results fast—often from day one.

Whether you’re undertaking a digital transformation initiative or looking to replace current spreadsheets and paper, PINpoint helps you take control of your medical device manufacture.