20 facts about FDA Approval Process for medical devices
Every company that plans to sell its meddev on US grounds has to register with the FDA. In the list, you will find key points of what awaits you.
What is medical devices lifecycle
What is the beginning of the medical device lifecycle, what is involved in the middle, and what is considered the end?
How to do an Offsite Audits
An offsite audit is the same as an on-site QMS audit, but the auditor engages with you via technology.
Extraordinary circumstances require extraordinary measures-Offsite auditing
Certain audits of meddev and processes are essential for companies if they want to place their product on the European market.
Cup of Joe #49 – Do You Need A Consultant?
When is the right time to hire a consultant? Do you need it and why?
It’s Official – MDR was postponed for a year
The European Parliament voted to suspend the implementation of the MDR by one year because of the coronavirus pandemic. This decision has been made.
Basic Terms in Medical Device Industry
To meet the requirements and the Regulations it’s essential to understand what is meant by keywords and phrases in the medical device industry.
QMS Manager role in MedDev industry
A QMS manager safeguards that standards are met throughout all processes of the company, from customer relations to manufacturing processes and all in between.
Interview with one of qmsWrapper’s successful User
Interview with one of the qmsWrapper Consultants – Emma Fortin. Read what she had to say about software and collaboration with the Support team.
Best Medical Device startups based on AI in 2020
Artificial intelligence research within medicine is growing rapidly. New technologies keep growing along with new discoveries, and so do meddev startups.
Top 10 MedDev conferences and summits to attend this year 2020
Attending conferences? Regardless of the current COVID-19 outbreak, this does not mean that you shouldn’t plan the next step for growing your business.
The European Commission proposed MDR delay
The Medical Device Regulation was due to become fully applicable on 26 May 2020, but COVID-19 has affected this matter as well.
Cup of Joe #48 – qmsWrapper: messaging from home
The COVID-19 outbreak is creating a massive challenge for many businesses. Millions of people are taking refuge from the coronavirus by working at home.
NEW MDR: May 2020 postponed
According to the latest EC news, the MDR deadline may have been postponed. As a result of the disruptions caused by COVID-19.
10+ essential things what MedDev startups must know
It is not easy to build a MedDev, and we all know that every beginning is hard. For startups, it’s quite a challenge. The more you know, the easier it is.
An effect of COVID-19 on upcoming quality and regulatory interactions
The spread of COVID-19 is being felt through the pressure on the WHO. Nevertheless, no delay in regulatory approval of meddev products has been observed so far.
Coronavirus Measures: How qmsWrapper feature helps you stay at "work" from home
COVID 19 has hit the whole planet, including businesses. Medical companies must be wondering how to stay ISO-compliant in this situation.
Medical Device Trade Shows after COVID-19
Based on the COVID-19 situation and the time when the pandemic is predicted to last, Medical Trade Shows are postponed. New dates are available.
qmsWrapper – Coronavirus (Covid-19) Statement
Quality Management System (QMS) Software qmsWrapper statement policy on Coronavirus COVID-19.
It's Your Own Data
qmsWrapper has a new feature that is helping you to be just one click away from securing your important data to your place!
Cup of Joe #47 - 2 Risk Modules
A new Risk Analysis Module is introduced to help focus on the relationship between requirements, design, and benefits, with an emphasis on risk-based design.
Enterprise-grade Processing Engine
Massive update of the year is happening and qmsWrapper’s Users will be thrilled to find out what is new in one of the 4 upgrades – Process Engine.
The New Risk Module supports risk-based design
The Risk Analysis Module becomes a very important update. Changes will make Risk Assessment much easier and clearer.
The Ultimate Content List of Technical File for CE marking
Some general details of the kind of information which will be required in the Technical File. As a general guide, the following items should be included.
8 things to know about CE approval process for Medical Devices
Determination EU Medical Device Directive which applies, Device Classification, Implementation of QMS, Technical File Preparation, etc.