Quality & Regulatory

DISCIPLINES

Quality & Regulatory Support

We support the quality and regulatory requirements of medical device manufacturing with our ISO 13485-certified quality management system and FDA registration. Every product we build is inspected, tested, and documented to meet them.

Overview

Quality and regulatory support keeps your manufacturing program compliant, from the first production build through long-term commercial supply. We help biomedical innovators maintain product quality through inspection and testing, generate the documentation regulators and auditors require, and manage suppliers to the same standards. Compliance is maintained throughout production, not checked once at the end. The result is consistent, documented quality that supports your regulatory obligations at every scale.

Inspection

Raw material, in-process, and finished product inspection, with environmental monitoring and routine equipment calibration and maintenance.
Testing

Biocompatibility, feasibility, verification, and validation testing during process design, validation, and commercial manufacturing, using external laboratories when necessary.
Documentation

Process verification and validation reports, DHF, DMR, and DHR records, procedures and work instructions, supplier records, and CAPA records.
Supplier Management

Supplier selection, qualification, performance monitoring, and risk management for devices, components, and liquid media.

PHASE 0

Process Development

Supports test methods and documentation for process design.

PHASE 1

Pilot Production

Leads inspection, testing, and documentation for initial builds.

PHASE 2

Manufacturing Transfer

Leads validation reports and establishment of the device master record.

PHASE 3

Commercial Launch

Leads inspection, testing, and documentation for the production campaign.

PHASE 4

Scale-Up

Supports supplier management and quality control as volumes increase.

PHASE 4

Optimization

Supports ongoing regulatory compliance and corrective and preventive actions.

Engineering

Design, validate, and maintain reliable, repeatable manufacturing processes.
Material Sourcing

Source and manage suppliers of equipment, tooling, materials, components, and services.
Manufacturing

Manufacture and assemble medical devices, components, and liquid media.
Quality & Regulatory

Meet quality and regulatory requirements with inspection, testing, documentation, and supplier management.