QA MED Solutions
Consulting on Regulatory and Quality issues for Medical devices.
We help you manage regulatory issues - so that you can maintain and improve your business
We help you to ensure compliance with MDR
We help small and medium-sized enterprises that lack a regulatory resource to ensure compliance with medical device legislation (MDR – Medical Device Regulation). We have many years of experience in the Medical device industry, and with our competencies we can ensure that you get control of documentation, processes and registrations, so that it becomes a strong competitive advantage for you. Our core competence is that we are good at making complex legislation – user-friendly and pragmatic, as we understand the everyday life in which you work.
We offer a wide range of services that you can see below.
MDR readiness and implementation
Examples are: Gap analysis, Clinical /regulatory strategy, preparation of Clinical evaluation and Technical documentation (primarily class I devices)
Quality Assurance: ISO 13485 QMS for medical devices
– or your own standard
Examples are: QMS implementation, Due diligence audit, QMS management, Training, Internal audit
Regulatory and Quality training and education
– customized for your needs
Examples are: EU MDR Compliance, EN ISO 13485:2016 QMS, Technical Documentation, Post Market Surveillance, Risk management, Quality Strategy Advice
Regulatory consulting
Examples are: Gap analysis, EUDAMED, Risk management ISO 14971, PRRC (Person Responsible for Regulatory Compliance), Regulatory affairs training, Regulatory Strategy Advice, CE-marking and labelling advice
Our team
The team behind QA MED Solutions consists of Rikke, Jutta and Karin.
Rikke Nygaard:
The backbone and founder of QA MED solutions. Since my high school years, I have worked with technical documentation on gloves through the company “EN Medipart”. Furthermore, my CV includes various courses in CE marking, Lead auditor in hygiene standards, Clinical evaluation, MDR implementation, Transition from MDD to MDR, Internal auditor – ISO 13485, Design control and Risk management IEC 60601. In addition to that I have participated in several groups for product standards – and currently I am a member of the ISO 13485 standard harmonization group. My special ability in the field of regulatory work, is that I place great emphasis on communicating the sometimes difficult-to-understand legislation so that it becomes easily accessible to those who have to work with it.
Jutta Kaiser:
I am the expert in Risk Management (ISO 14971) and the one with the view from “the other side of the table” -ie. I have many years of user experience working as an Intensive care nurse and therefore I have extended knowledge of various advanced medical equipment. In addition to this I contribute with my project management qualities achieved as a Team leader on operational projects that had a focus on achieving “Best practice”. In QA MED Solutions I am the expert on preparation of Technical Documentation, and have both by virtue of my experience and a course in risk management, a keen eye for what to pay special attention to.
Karin Jørgensen:
My passion is, and has always been, to work with writing procedures that reflect the best way of working – both for employees and for customer satisfaction. This was offset by a course in “LEAN management in practice” and “Project management”. This combined with a Masters degree in Business, Language and Culture and 15 years of experience working with sales of medicine and medical devices – I have a lot of experience in creating workflows that focus on value for the customer in the most efficient way. My CV includes implementation of ISO 13485, Quality management for medical devices & Internal auditor(Medico industrien), MDR course (DNV), CE-marking of medical devices (medico industrien).
Our mission
Our mission is to help improve patient safety and health by supporting medical device manufacturers with market access and achieving and maintaining regulatory compliance according to the new MDR.
We strive to do this as your partner with a practical approach balancing business needs and regulatory compliance.
Looking for help?
Write to info@qamed.dk
Rikke Nygaard
Senior Consultant & owner of QA MED Solutions
Phone:+45 24 65 58 85
Email: Rikke@qamed.dk
Jutta Kaiser
Project Consultant & nurse
Phone:+45 53 83 58 85
Email: jutta@qamed.dk
Karin Jørgensen
Senior Consultant
Phone:+45 53 68 58 85
Email: Karin@qamed.dk
