Quality Services - SG Medical | QUALITY & REGULATORY

Quality engineering

SG Medical QA experts are involved from day one in the product development cycle to mitigate risks and improve the process of the product’s manufacturability.
They have a broad experience in product design, manufacturing and engineering.
SG Medical teams assist customers at all stages of the product development to meet FDA, EU, and ISO 13485 requirements and recommend regulatory strategy QMS compliance.
They are specialists in statistical sampling for validation, process control and verification and drive constantly the improvements of manufacturing and quality control.

Process Validation

Design Development Planning
Process Validation Master Plan (VMP), design assurance and design control experience including design test strategies, design Verification & Validation support for customer product approval
Risk Analysis and Risk Assessment (aFMEA / dFMEA / pFMEA/ Hazard Analysis etc.)
First article layouts and approvals
Process Capability Studies (CpK, PpK, Tolerance Intervals)
Validations including IQ, OQ, PQ, PPQ, Test Method development and TMV’S
Lab testing for analysis and compliance
Software validation

We share with our customers the commitment and responsibility for regulatory compliance.

We partner with customers to generate and/or maintain:

Design History Files (DHF): Bill of Materials (BOM) Flow Charts, Specifications, Drawings, Work Instructions, Job Travelers and Inspection forms Device Master Records (DMR)
Device History Records (DHR)
Post-Market Surveillance Reports
Complaints Reporting
Product control and traceability through every stage of the lifecycle of the product
COC/COA/ MSDS delivered for every product (single /Batch) we release to customers

Quality inspection

We use different quality tools from material inspection, to finished product release:

Incoming controls:
Each attribute of the components and the finished device will be inspected according to a pre-established sampling plan taking into account their criticality as well as a document conformity check in line with MDR / FDA standards (COC, COA, MSDS).

Final Inspection:
To ensure we meet our clients’ requirements and the product specifications, a consistent set of requirements is clearly defined for finished products inspection and release.

Equipment Monitoring:
As an ISO 13485 certified firm, we strive to maintain a high standard for our equipment park to provide a first-class service in manufacturing products meeting our customers’ expectations.

In order to ensure availability and proper functioning of our infrastructure, equipment and measuring tools used in production, we define and update consistent requirements for maintenance activities, calibration and verification.