“Sigma has become an integral part of our quality system. Steven Skerritt and his team work closely with our internal team, not only to audit our operations, but also to develop and train our people. Together, we achieve a cohesive approach to continuously improving our quality system. Our business performance metrics have never been better.”

“I worked closely with the Sigma-SOS team, specifically Steven Skerritt, for several months working on a validation project. He was so very easy and awesome to work with in an area I was not very familiar. He was patient, informative, and always willing to go the extra mile to help in understanding and the with the work involved with the validation program. The project was timely, attention to every detail and ahead of schedule. His professionalism was without a doubt as awesome as the work performed for our team. He was also willing to drive hundreds of miles if needed to help with implementation or any other facet of the project.”

“After hitting and missing with another consultant, we engaged Sigma-SOS to assist with a 483 remediation project. This was no easy task given our small size and limited resources. The team at Sigma-SOS stepped in and quickly came up to speed on our business and the issues. A plan was outlined, and with the support of our consultants, Steve and Penny, we systematically worked through each issue over a period of weeks that turned into months. Their calm demeanors, layman’s approach, and depth of expertise gave us tremendous confidence throughout the process, and by the time we reached our mock audit, the company’s QMS system had gone through an amazing transformation. Perhaps the most beneficial aspect of working with Sigma-SOS was Steve and Penny’s real-life experience, having spent many years working in industry maneuvering through the exact challenges we were facing. I would highly recommend Sigma-SOS for any regulatory projects, both large and small.”

“Steve Skerritt gave us an amazing jump start on our Quality Management System and worked with us in quickly and painlessly attaining ISO13485:16 certification. Steve Moore was a great asset as he stood by us through the audits and provided guidance with our documentation. These gentlemen acted as our lifeboat in a storm of red tape and still offer advice when we call upon them. We are eternally grateful for all of their expertise and assistance. They helped to make our audits confident and stress free.”

“We engaged Sigma-SOS to help our company develop and implement a world class QMS system for our company. Being a start-up manufacturer, we had a tight time-line, and a tighter budget, and Sigma-SOS delivered on both fronts. Sigma-SOS helped us to develop and implement a system that met all of the requirements, robust enough to pass numerous audits, but is still user friendly enough to be practical for everyday use. We could not be more pleased by the ongoing service and support that Sigma-SOS has provided, including internal audits, calibration, training, registrar audit prep, and continuous improvement efforts. Starting a business in this environment can be difficult, and we could not have done it without Steve and his team at Sigma-SOS.”

“We have been working with Sigma-SOS in different facets over the past several years, either through audits, gap assessments pertaining to ISO 13485:2016, and quality systems architecture and design. It has been a pleasure working with Sigma-SOS to build and grow our quality system. Their professionalism and knowledge, in addition to their positive attitude, has been instrumental in the success of our quality system here at Summit City Medical.”

“Working with Sigma Operation Services has helped Horizon MDM Inc to improve our quality policy and to guide us through the ISO Audit process. They have also played a large role in our Validation process for machines and the work instructions needed for different operations. Great company, great people, Thanks.”

“Sigma-SOS has been a great resource for our shop. The majority of our work comes from the orthopedic industry and both Steve Skerritt and Steve Moore have been instrumental in getting our quality system up to industry standards and keeping us up dated on an ongoing basis. They helped us implement the quality system. And they perform annual reviews to make sure we are following all the quality system processes they helped us create. They have gone above and beyond in servicing our shop even though we are not as big as many of their other clients. They have been a vital part of our success.”

“I can’t recommend the consultants at Sigma SOS highly enough. Steve and Penny were like a positive addition to our company’s quality department. They went out of their way to work within our schedule and budget to help navigate us through a lengthy 483 remediation. They made sure they understood the nuances of our processes and product line to find the most efficient ways our small company could meet all regulatory requirements.”

“We want to thank you for the excellent Regulatory Consulting we received. We could not have improved the structure our Quality System to comply to the full expectations of the FDA and our new Distributors so quickly, without your experienced guidance. You are always accessible and professional with your quick responses to our Quality questions. We enjoy that you both are so personally engaging and such a pleasure to work with. We look forward to our ongoing working relationship.”

“We have been working with Sigma-SOS, for the past 4 years, and have been extremely happy with their services and professionalism. What started as machine validations for our CNC machines 4 years ago, has grown into them performing all of our internal audits as well. Their expertise in both ISO 9001:2015 and ISO 13485:2016 have helped us pass 2 surveillance audits and our recertification audit for both standards, with flying colors. Their findings are always firmly based on the standard and OFI’s always add value to our processes.”

“We have been working with SIGMA-SOS for a number of years now and it has been a true pleasure. Steve Skerritt is unmatched in his ability to understand QMS standards, specifically for the orthopedic medical device industry such as ISO 13485, and how it practically relates to meeting customer’s needs. They have been a great partner in helping us with internal audits, IQ-OQ-PQ’s, validations, and all matters quality related. I would recommend Steve and his team without hesitation!”