References
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Quality is our job
To develop products and to get them ready for the market is one thing. Optimum quality you can rely on is the other. Therefore, quality management according to ISO 9001, EN ISO 13485, ISO/ASTM 52920 and based on 21 CFR Part 820 (FDA), ANVISA and JPAL has top priority for Samaplast.
Risk management
Risk management without compromise
Risks are an inherent part of our job. We bear a great responsibility in the production of our medical devices, because ultimately life depends on them.
Therefore, a functional risk management based upon EN ISO 14971 is a central task of company management. Such conduct is of existential importance for our customers and partners, their end customers and ultimately for our company. We accept these responsibilities. For our customers, for our staff, for our business.
Validation
Evidence of suitability through process validation
That which we develop and manufacture, must also function. Therefore, it is part of our task to provide evidence of suitability by means of a process validation (e.g. in accordance with GHTF). Within this validation, we need to demonstrate that our main and secondary facilities are qualified for production.
The following documents apply to the implementation of qualification and validation
- Qualification master plan (QMP)
- Validation master plan (VMP)
Measurement methods
Precision is measurable
A component in our quality work and quality assurance is precise measurement in all areas and variations. In order to avoid even the smallest errors, we rely on the most diverse measuring techniques and methods, which are carried out by our highly qualified and specially trained staff. The capability of the measuring systems is validated by means of MSA (Measuring System Analysis). This is because for us, trust is good, but control is safe.
Measurement methods
- Modern 3D coordinate measuring machine
- Video measurement system
- Tension / compression testing machine
- Computer tomography (CT) inhouse
Aim of the measurements
- Measurement of complex geometries
- Creation of a variance analysis
More of Samaplast
Engineering
Engineering - a component is made