ISO 13485 is the fundamental standard within medical devices. PAJ is able to develop products and manufacture according to ISO 13485.

ISO 13485 consists of

• Monitoring of regulations
• Control of work environment to ensure product safety
• Focus on risk management
• A range of specific product requirements

The advantages by ISO 13485 is

• Safe medical equipment
• Ensurance that product lives up to all regulations
• Use of best practises in the product development

Medical equipment - product cases

PAJ has for a medical company developed and manufactured an anastesia ventilator. When developing medical products, it is important to use a supplier certified according to ISO 1385. Read more about it here.

PAJ is always ready for a detailed dialogue regarding a potential project, demanding development or manufacturing according to ISO 13485.