WHY DO COMPANIES CHOOSE US FOR MEDICAL MOULDING?
- 1Medical quality standards. We can manage a medical moulding project of any complexity: from self-sealing micro-moulded endodontic obturation points, weighting less than a 0,1 of a gram to innovative urine-testing medical devices and biodegradable catheters.
- 2Cleanroom conditions. Classified ISO 8 Manufacturing, localised ISO 7 Manufacturing – no contamination and low bioburden.
- 3Stable manufacturing process. Validation of the medical injection moulding process is extremely important. We’ve created a 16 steps validation plan to make sure your manufacturing process is stable.
- 4Latest quality standards for medical moulding: 1) ISO 13485: 2016 – latest standard, manufacturing of your medical devices is fully traceable; 2) Directive 93/42/EEC on medical devices; 3) CE mark – we can gain all requirements and standards for you to market the product