Medical Devices heading towards CE - our passion
This is life for you as young medical device manufacturer: Your product ideas are perfect. Technical and medical know-how is brilliant. There is pressure to go to market. Patents are waiting to be used. Investors seek quick revenue.
In this situation the big impact of legal, regulatory and quality is often forgotten and implemented late. Development of your device has to consider safety and health of the patient in each single step. It takes time until everybody in your company has developed sensitivity for legal impact.
This field is Astracon's core competence!
We develop a regulatory and quality management system and structured roadmaps to CE. Close cooperation with you helps adjusting perfectly to your needs and your product. We take the coordination part.
Nobody knows everything. For the gaps we cooperate with partners: We can be quick and flexibel by by making available our network to you.