I’ve enlisted NJK Consulting for more than 6 years for assistance with pre-market submissions, design change impact analyses, vendor audits, verification and validation planning, conduct of usability testing, and to act as independent reviewer. In all of these areas, Natalie and Roger bring in-depth regulatory and technical expertise that enables them to jump to the heart of the issue and to provide practical advice and solutions. Gynesonics has additionally adopted the design control procedures developed by NJK Consulting; these procedures and templates are very practical and easy to use. Natalie and Roger have assembled an excellent team of talented individuals, and it is a pleasure to work with them.
NJK Consulting has provided us with great support and professional advice. They are results driven and that matches our expectations for external partners.
I have found that NJK & Associates delivers hands-on comprehensive regulatory services associated with medical products and, with their collective experience and intellectual horsepower, they are an ideal fit with our company when we need regulatory and quality systems guidance in our diverse medical product development environment. They have the added benefit of experience in design engineering and production engineering and are a quick study when briefing them on technologies under development. As a result, they present sound strategies for practical solutions to compliance activity while sensitive to company culture.
NJK can help navigate the regulatory pathways and set up Quality Systems for startup medical device companies and I have also seen them rescue large companies who are faced with unexpected post-market challenges. They are my “go-to” resource and I can depend on them for their seasoned experience when I’m grappling with regulatory issues that apply to unique or novel technologies when developing medical products that are headed toward a 510(k) Premarket or PMA submission to the FDA.
NJK Consulting is a full service organization when it comes to Regulatory needs. Whether you simply need guidance or their complete efforts in making a submission. The assistance that Natalie and Roger offered enabled our organization to receive approval for a Class III device in Canada within the most minimal time frame following submission. NJK Consulting is thorough, customer oriented and most importantly, knowledgeable about Regulatory requirements for the U.S., European Union and Canada.
Our interactions with Roger and Norm of NJK Consulting has been nothing short of exceptional. These guys took the time to understand our Quality System as it relates to SAI’s manufacturing processes and ISO requirements. We have utilized NJK services to update different aspects of our Quality System, as well as worked with them on a product for a mutual customer to improve the products manufacturability.
Roger and Natalie are trusted partners who deployed very quickly and stabilized the quality and regulatory groups within the company and acted as the defacto leads of the group. With their leadership, we remediated some findings, and unblocked several submissions. Roger’s quality system backbone has been the center of our way forward. Cannot say enough how appreciative we are for their expertise.
I started working with Natalie in 2004 while CEO of PLUS Orthopedics. During that time she helped the company survive some challenging regulatory issues that started prior to our joining the company.
Since that engagement I have worked with Natalie and Roger at two subsequent companies.
At Medacta I hired NJK & Associates to design and implement a compliant and practical quality system, and to choose, install, and validated the equipment used in our reprocessing and distribution center. During this time they also wrote more than 20 successful submissions to FDA for new orthopedic systems.
In my current position as CEO of Game Ready I use NJK to provide experience-based advice on a number of topics related to regulatory issues.
They have proven over the long haul and across many challenges to be assets to my companies.
Working with the NJK team and more specifically Annamae, has been nothing short of exceptional. They are diligent, responsive, and simply flat out excellent at what they do. They have made every aspect of compliance for our organization complete and I could never envision being in business without NJK and Annamae on our team too. I would HIGHLY recommend them.