Ready or not - the new European Medical Device Regulations (MDR) are coming!
👉 The first post in our blog post series, where we discuss about the new MDR and its effects. This one discusses shortly about WHYs, WHATs and WHENs.
👉 This blog post includes our tips on how to balance the regulatory compliance with medical device design and development process; like how to recognize all the needed fundamentals, specifications and requirements set by authorities, patients and end users, to get the market access on time.
The jungle of rules and regulations in medical device business – is it a nightmare or a fairy tale?
👉 Someone could say that bringing a medical device or an IVD device to market can be a nightmare. It’s often narrated as demanding process full of confusing regulatory standards and regulatory authority certifications that must be complied with and which must be integrated into the design and production of the device. But is it really a total nightmare? We shared our thoughts related to the topic in this blog post.
👉 In this blog post we first discuss a little about these three methodologies (Design Thinking, Lean Start-Up, Agile), and then we describe how they interact and how they can be applied in medical device design and development. We also highlight one important question: WHY to do so - what are the benefits of applying these three methodologies in medical device design and development?
FDA rules and regulations - tips for medical device companies for US market entry
👉 To fasten your product’s way to US market, you should ensure that your team is familiar with FDA regulations, which are a must for companies heading the US market. In this blog post we shared our tips for medical device companies for US market entry.
How to co-create medical devices in an agile way?
👉 We’ve found that agility can be achieved in medical business despite the burdensome regulations and more complex business environment. More about the topic in this blog post.
Achieve more agile medical device development cycle by putting more effort on the idea phase
👉 We see it is very important to put more focus on the idea and conceptualization phase when designing and developing medical devices: with the right choices made already at that phase, the more agile project schedules can be achieved. But what kind of things should be recognized already when coming up with the new idea? In the blog post, there are a few essentials to keep in mind in the idea and conceptualization phase of medical device development.
Why you should care about rules and regulations in medical business?
👉 One clear reason for the importance to follow and meet the rules and regulations in medical field is that if you won’t meet them you’re not able to enter the certain market you’re trying to enter in. But actually, there’s important reasons for that, too, WHY you cannot enter the certain market unless you haven’t followed the rules. In this blog post we discuss more about why are rules and regulations needed in medical business, and why it is that important to follow and meet them.
Prepare your QMS to the new MDR – tips available!
👉 Because the recent updates to EU medical device regulations will have a significant impact on every medical device manufacturer’s quality management processes, we wanted to discuss and share some tips on how to proceed in implementing the new MDR to your Quality Management System.
FAQs about quality compliance and regulatory affairs in medical business
👉 Finding answers? Follow the link above! Behind the link there 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 affairs in medical business.