Recent news, articles & releases

Recent Posts

Prepare your QMS to the new MDR – tips available!

The new Medical Device Regulations (2017/745/EU) (MDR) will replace the existing Medical Devices Directive (93/42/EEC) (MDD) and the Active Implantable Medical Devices Directive (90/385/EEC) (AIMDD)....

Ready or not - the new European Medical Device Regulations (MDR) are coming!

The new Medical Device Regulations (2017/745/EU) (MDR), published in May 2017, will replace the existing Medical Devices Directive (93/42/EEC) (MDD) and the Active Implantable Medical Devices...

Co-creation and standardized working methods bring agility to the regulated MedTech world

MedTech as a business is changing and getting more complex. For example, the technical complexity and regulatory requirements are something that are increasing as we speak. At the same time there is...

The benefits of applying Design Thinking, Lean Start-Up and Agile methodologies to medical device design and development

Across industries, the pace to introduce new products is increasing. This puts pressure to shorten the design and development cycles. Medical devices are no exception in this respect.

Ensure the quality compliance of your medical device – learn about the regulatory process in practice

Do you have an idea of a medical device? Or have you already started to develop your medical device? Do you want to enter, e.g., EU or US markets?

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 regulatory...

Achieve more agile medical device development cycle by putting more effort on the idea phase

There’s few common trends in the medical field, which have a clear effect to the development of new medical products. The first one is the constantly changing jungle of rules and regulations, which...

How to co-create medical devices in an agile way?

Across industries, the pace to introduce new products is increasing. This puts pressure to shortening the design and development cycles. Medical devices are no exception in this respect.

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...

1 ...
2 3 4 5 6

Subscribe to our newsletter

how to ensure the quality compliance of your medical product

Archives

see all