Our purpose
We Help Improve Patients’ Quality of Life.
We help enhance patient outcomes and quality of life. Our training and consulting support assists our medical device clients in designing and manufacturing their products and bringing them to market more quickly, effectively, and efficiently. Products such as improved hip implants allow a grandmother to pick up her grandchild, and insulin pumps free a child to play soccer without fear. Helping to optimize patients’ quality of life is why we come to work each morning.
About us
We’re 100% focused on enhancing regulatory compliance, and achieving sustainable outcomes.
Iris Diagnostics, Inc. is a global consultancy and training firm focused on in vitro and medical device regulatory compliance, quality management, auditing, and training for US and international regulations. Formerly RM Clinical Consulting, Iris Diagnostics was formed in 2019 as a group of industry professionals seeking to work together and provide prospective clients with a complete set of solutions. Industry and governmental clients have come to trust us for our deep subject matter expertise and proven ability to deliver long-term results. Our fluency in regulatory requirements and improvement methodologies allows our customers to boost performance while safeguarding or improving their regulatory compliance. Read more about our areas of expertise.
A long history of leadership and innovation in QA/RA.
We strive to become an industry leader in assisting in vitro and medical device manufacturers at every step, from achieving compliance with FDA and international regulations to making processes more effective and efficient. Our goal, then and now, has been to enhance the quality of our customers’ products to help them improve patient outcomes.
Our Core Values
Happy Employees Do Great Work for Customers
We develop and empower our employees to grow and prosper to their fullest potential. When our employees are happy and challenged, we can help our clients achieve their full potential – which, in turn, improves patient outcomes and quality of life. Our processes and decisions are focused on ensuring that our trainers and consultants have the resources they need to deliver superior service to our clients. We also strive to proactively mitigate the burdens that travel places on our employees’ families and work responsibilities in order to foster an optimal work/life balance.
Doing the Right Thing for Mutual Success
Our founder’s philosophy was to build relationships based on doing the right thing for our clients and suppliers. By listening carefully to our stakeholders, we can understand their needs and deliver solutions that exceed their expectations and ensure mutual success. We practice what we preach and deal ethically and fairly with everyone. This benefits all parties involved.
Diversity is a Competitive Advantage
We believe that a successful team includes a broad range of people, perspectives, backgrounds, and ideas. Diversity and inclusion are a way of life at Iris Diagnostics, and our employees represent different cultures, religions, genders, ages, sexual orientations, and experiences – thus enhancing our overall employee experience and customer satisfaction. We don’t believe in cookie-cutter approach to hiring talent.
We Invest in Our Consultants
The vast majority of our consultant team are full-time, employed professionals who apply their knowledge and skills to our ever-growing portfolio of clients and projects. We invest heavily in our people through skills training, personal and professional development. Simply hiring ‘contract’ work to plug a client need runs contrary to our Culture and Philosophy.
We Take the Long View
We have funded our business for 10+ years without the use of outside capital. Our staff make up the backbone of our business and we consider their time and dedication to be the only investment we need. We aren’t pressured by short-sighted investors, we are able to make investments and decisions that are best for our employees, our clients, and the long-term outcomes for our firm. We place great value in sustaining relationships that last and ensure mutual success.
Area of expertise : Consulting & Auditing
Iris Diagnostics, Inc. fuses our expertise in life sciences, quality management systems, and performance improvement methodologies to help our customers meet regulatory requirements and boost results.
In Vitro RA/QA Consulting
Medical Device RA/QA Consulting
Leverage our team's experience to achieve and maintain US FDA and global regulatory compliance with training and consulting support for the entire product life cycle.
Quality System Audits for FDA's QSR, ISO 13485, MDSAP
Find expert, outside support for supplier, internal, and FDA mock audits. Unlike registrars and notified bodies, our auditor consultants are allowed to both identify deficiencies and help you design effective solutions.
Performance Excellence
Improve processes, cut costs, and increase customer satisfaction with proven improvement methodologies such as Lean and Six Sigma. Iris Diagnostics expertise in performance excellence and regulatory requirements ensures sustainable performance improvement.
ISO 9000 & Related Standards
Implement a QMS that complies with globally recognized management standards like ISO 9001 and ISO 13485.
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