Quality & Regulatory

Quality and regulatory, built in

Quality and compliance run through everything we do, from a quality management system aligned with ISO 13485 and MDSAP to hands on regulatory support that helps your product reach the market and stay there.

ISO 13485

Medical Device Quality Management

Documented, controlled processes
Risk based quality management
Continuous improvement

MDSAP

Medical Device Single Audit Program

Single audit, multiple jurisdictions
Recognized by participating regulators
Supports international market access

GMP Guidelines

Good Manufacturing Practice

Controlled manufacturing environment
In process quality checks
Batch records and release documentation

Sterasure's Quality Management System (QMS) is certified as being in conformity with ISO 13485 by Intertek.

What We Do

Quality & regulatory support

An experienced team supports your product from design through post market, so compliance keeps pace with development.

Quality management system aligned with ISO 13485 & MDSAP
Design controls and risk management (ISO 14971)
Document control, CAPA, and change control
Supplier qualification and material controls
Regulatory strategy and submission support (Health Canada & FDA)
Verification and validation support
Qualified clean room facilities
Environmental monitoring and controls
Technical documentation and labeling support
Audit readiness and post market surveillance support

Our Commitment

Compliance that keeps pace

Quality and regulatory aren't a final checkbox, they're built into every stage of how we work, from design controls through post market. Our team helps you anticipate requirements early, so compliance moves at the speed of development rather than holding it back.

To request more detail on our quality systems or certifications, get in touch.