Title: Welkom bij QAid Descriptive info: .. Welcome.. |.. For whom |.. How does it work |.. What is the result |.. Get acquainted |.. Links & downloads.. Koekoeklaan 5A.. 5737 PM Lieshout.. The Netherlands.. +31-(0)499 427955.. +31-(0)6 10696311.. post@QAid.. nl.. QAid offers an efficient, reliable and effective way towards the acknowledgement of the.. quality.. of your ... quality systems (ISO-13485), product development and project management to companies in the.. medical device.. and in vitro.. diagnostics.. industry.. QAid offers you more than 15 years.. experience.. gained directly from within the healthcare industry.. The majority of QAid clients can be described as being primarily small and medium sized innovative companies..
Title: Welkom bij QAid Descriptive info: Welcome |.. For whom.. For whom? Test.. QAid clients typically want room to focus on their own field of expertise and have therefore created a network of high skilled professionals for issues in specialist areas beyond this field.. Getting to the.. market.. with safe, high quality ... That's why they chose QAid.. To help with or take over the management of.. Regulatory.. approvals.. such as CE MDD or IVD.. Quality systems, such as ISO 13485.. Quality management.. Risk Management according to ISO 14971.. Project management.. Strategic product requirement definition.. Being your Authorized Representative..
Title: Welkom bij QAid Descriptive info: How does it work.. How does it work?.. The key word is ".. uncomplicated.. ".. We keep it simple because none of our clients want to create a pile of paper or to maintain tedious systems.. Neither do we.. We know that only those.. straightforward.. solutions that fit your line of business will work.. We offer you low-maintenance solutions with a beginning and an end.. Not high-maintenance long-term projects.. We want our clients to be.. successful.. because we helped them improve their business.. Clients who will recommend our work to others.. Therefore QAid ... work.. That's why QAid starts with a face-to-face meeting for an immediate inventory of your request and of the match with your company.. QAid let's you know without delay exactly what QAid can do for your company.. Next you'll receive a plan.. The plan includes clear steps towards the solution, timing and budget and for those important milestones along the way.. Once you have been convinced about how QAid can help your business, the.. co-operation.. can start.. If not, no harm done, no invoice.. It's that simple.. Because.. clarity.. is our middle name..
Title: Welkom bij QAid Descriptive info: What is the result.. What is the result?.. Satisfied customers who have.. achieved.. their goals.. This is the only result that counts.. Results obtained by clients of QAid include:.. A.. simple.. , efficient and.. effective.. quality system according to ISO 13485.. CE MDD and CE IVD.. certificates.. Project plans.. ... your Authorized Representative.. Or an experienced consultant in your team, helping out for as long as you need.. Results have been achieved at innovative companies like:.. Vital Scientific - Organon Teknika - Organon - Panton - bioMérieux - NTOC - Medspray - Sonoco Crellin - Klapwijk Industries - KitoZyme SA..
Title: Welkom bij QAid Descriptive info: Get acquainted.. Would you like to get to know QAid.. and.. at first hand? You are.. welcome.. at:.. Tel: +31-(0)499 427955.. Mobile: +31-(0)6 10696311.. Email:.. nl.. Best regards,.. Wim Jansen.. owner QAid..
Title: news Descriptive info: Links below give access to the key documents describing the EU and the USA regulations.. For questions on application and interpretation of these documents please contact QAid at.. The text of the Medical Device Directive:.. MDD-text.. and of the In Vitro Diagnostic Medical Devices Directive:.. IVD-text.. Standards to show compliance with the Essential Requirements of the Medical Device Directive:.. MDD-standards.. and with the Essential Requirements of the In Vitro Diagnostic Medical Devices Directive:.. IVD-standards.. Get your standards for example through.. NEN.. Notified Bodies play a major role in the assessment ... Bodies (MDD).. and for In Vitro Diagnostic Medical Devices:.. Notified Bodies (IVD).. Registration of manufacturers and devices are needed at the.. Competent Authorities.. European guidelines supporting interpretation and implementation of the Medical Device Directive and In Vitro Diagnostics Directive:.. MEDDEV.. CDRH.. is that part of the FDA dealing with medical devices.. The FDA recognizes many international standards to show compliance with regulatory requirements:.. FDA Recognized Standards.. Are similar devices on the USA market? Then you probably can use the.. 510(k)-route.. CDRH gives lots of information on how this route works..