Innokas Medical Business Blog

Tiina Kotipalo

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Head of QA&RA
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FAQs about quality compliance and regulatory affairs in medical business

Finding answers? Welcome! - This is an unofficial guidance which is intended to assist medical device OEMs by answering to some common and basic questions concerning quality compliance and...

Quality Management System - one key to success

When you’re working in medical industry, it’s a fact that regulations and standards are something that companies need to follow and they’re coming stricter for everyone continuously. This is...

Tips available! How to balance the regulatory compliance with medical device design and development process?

When creating a new medical device to the market, there’s much more that goes into designing, developing, and introducing a medical device to the market than simply coming up with an innovative...

Why you should care about rules and regulations in medical business?

Bringing a medical or an IVD device to market can be a nightmare of confusing regulatory standards and regulatory authority certifications that must be complied with and which must be integrated...

The jungle of rules and regulations in medical device business – is it a nightmare or a fairy tale?

The design and manufacturing of medical devices is way more challenging than engineering work and factory production of e.g. consumer electronics. In medical device business, it is not enough to...

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how to ensure the quality compliance of your medical product

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