our values
working together.
doing the right work.
doing the right work.
We have open dialogues, a positive attitude and we team up to success with other great partners, leveraging each other's knowledge, competence and expertise to provide our comprehensive services as promised.
doing the right work.
doing the right work.
doing the right work.
With our hands-on practical experience, we deliver quality services to our clients, focusing on results and seeing things through.
We are committed to honesty, trust, and transparency and we do the right thing even when no one is watching.
getting work done.
doing the right work.
getting work done.
We take our work seriously and strive to deliver exceptional results for every project so that you can get safe medical devices to your patients and users.
We take an outside perspective to overcome obstacles and find solutions together with our clients.
loving our work.
doing the right work.
getting work done.
We love what we do, and we do it with love.
We constantly learn, improve and develop, staying on the cutting edge to provide a service that’s anything but basic.
testimonials
Sharon is one of the best all-around QA/RA Consultants that I have worked with. She understands the industry, the regulations, and the balance between business needs and compliance. She handles audits exceptionally well and effectively manages her projects. She is able to navigate in complex, matrixed organization. Sharon is a strong asset to any organization. (Ari Levin, former colleague, Physio-Logic)
Sharon is a professional quality and regulatory manager and consultant with vast knowledge in medical device, quality management systems, regulatory submissions and other aspects of the job. Sharon is a true leader, a great team member and excellent communicator. Over the past few years I've had the pleasurer of working with Sharon on a number of projects and I highly recommend her for any QA/RA project or role (Iris Hanochi, Owner, IRisolve)
I wanted to write to you personally - thank you so much for the support and help lately. Your availability and professionalism should not be taken for granted and you have given me so much beyond my expectations. I totally feel like you upgraded me in a few levels in such a short period of time that we worked together. (Meytal Yogev, QA/RA Manager, 270Surgical)
Sharon works with us on CE MARK submissim. Sharon is very professional. She assists us in building and managing a very tight submission, including providing document templates, guiding us through all the needed standards and directives.
Sharon is always available for quick answers as well as thorough and tight guidance and support (Varda Karpati,
Director of Regulations, Newsight Imaging)
Sharon and I worked together for a decade. Sharon is an extremely dedicated, hardworking, and devoted professional and she is highly appreciated by peers, partners, and customers. Sharon is a certified, qualified, and very experienced quality and regulatory expert. She served in multiple roles and company structures starting from a medical startup growing into international corporate arena following our company’s acquisition and finally as an independent consultant to many firms. She is highly appreciated and recommended by all who worked with her over the years (Doron David, CEO, Commwell Medical)
I considere that working with Sharon is a privilege. The wiser QARA consultant i have work with. Sharon has the exceptional skill to think at all aspects, including technological aspect.
I am also impressed by her wide and accurate knowledge and extended experience in most of thestandards, MDR, ISO13485, FDA, all MDCG'S , and much more that i have not meet yet in my work. She has succeed all the time in our audits to avoid findings, impressing also auditors and NB's by her professionalism. She performs all QA/RA tasks (also taking important part in ECO'S, CAPA's, TF Technical Doc sreviews and writing) with excellence, high level, and on time delivery. Associating strict regulatory aspect and mind flexibility, she fits all type of companies: small, big, beginners, experienced....
Her kindness, patience, wish to help and transmit her knowledge, cooperation, dynamic andcreative solutions are precious and always enriching. She knows how to speak with the most problematic person and motivate him to do the work needed the right way. People are respecting her and listening to her naturally. I wish she will continue be our main QA/RA resource, we can count on and be quiet, we do the right thing the best way. (Sarah Atias, Production Manager, RND project manager and QARA, Image Navigation)
Sharon played a crucial role in assisting with various QA/RA challenges. Her expertise in navigating complex regulatory requirements, coupled with a deep understanding of quality management, significantly contributed to our success in achieving and maintaining compliance. (Fira Rozenfeld-David, QA Manager, Nanox Vision)
Sharon was my colleague in Physio-Logic, A Medical Devices consulting house, for 4 years. Sharon is very versed with FDA and CE submissions to Notified Bodies, Internal Audits both in Israel and USA, creating Technical Files for Class III devices and QMS. Sharon is a diligent professional and fully dedicated to her work. Her knowledge is outstanding in a way that often colleagues approached her to ask for advice and opinion about complicated issues. Sharon used to complete her tasks with a short time and gained praise from the customers. Sharon is considered as excellent consultant among the Medical Devices consultants in Israel. (Ilan Goldberg, former colleague, Physio-Logic)
Sharon is a high-level specialist, a reliable partner with excellent communication skills. Every project she takes on is guaranteed to succeed. I recommend her without reservation.
(Vika Mickel, RA Manager, Nanox Vision)
I am delighted to recommend Sharon as an exceptional consultant in QA/RA. Having worked closely with her, I’ve witnessed firsthand Sharon’s deep expertise in navigating regulatory requirements and ensuring seamless compliance with global standards. Her guidance was instrumental in achieving critical quality and regulatory milestones.
In addition to her technical expertise, Sharon shines in her collaborative approach and unwavering dedication to quality. She consistently brings a personal commitment to excellence, going above and beyond to ensure success. Sharon is not only a strategic thinker but also a genuine pleasure to work with, making her an invaluable asset to any team. (Ira Mirkin, QA/RA Manager, Chronisense/Polso)
I wanted to take a moment to express my sincere gratitude for your exceptional work on the recent audit. Your expertise and dedication made a significant impact on the results and contributed greatly to our success. Your attention to detail and the consistently high quality deliverables you delivered are commendable. Your punctuality while maintaining a high level of professionalism is commendable. In addition, I would like to commend your excellent interpersonal skills. You have a clear and concise way of communicating complex information
with great employee engagement. We have generally noted that your approach makes working with you easy and pleasant.
We appreciate your commitment to excellence and your willingness to share your knowledge with us. Thank you for your amazing work. (Yaniv Luria, Office Manager, Image Navigation)