Validation Services for Medical Equipment Manufacturers

Quality you can trust – ISO13485 (medical) and ISO9001 (manufacturing) accreditation

Validation Services

Our commitment to excellence extends to our validation service. We will prepare a bespoke master validation plan and validation protocol for you including a full production part approval process (PPAP). This will include IQ (Installation Qualification) documentation, a process flowchart, OQ (Operational Qualification) trial, metrology report and PQ (Performance Qualification).

Validation Process for Medical Injection Moulding Projects

Your plastic injection moulding project is assigned a dedicated project manager who oversees the project to successful completion
A timing plan detailing key milestones is agreed with you at the start of the project
Regular project status updates are supplied to your nominated contact
Your dedicated project manager provides a central point of contact for all aspects of your project

Injection Moulding Product Quality Process

Accredited to ISO9001:2015 & EN ISO13485:2012.
Dedicated work instructions for each part to include key dimensions and aesthetic requirements as agreed with you
Cross check to master sample on each batch to ensure product quality is maintained
First off patrol checks (every 2 hrs) and last off checks as standard
Batch file for each works order with full traceability of material, drying equipment, machine, patrol check results approved by quality assurance
Full range of metrology equipment to include CMM, OGP, DTI, micrometres, height gauges and vernier callipers.
Hand over process on project completion to dedicated QA engineer and account manager for ongoing support