We guarantee your successful ISO 13485 registration and we guarantee you can’t get an easier or more effective ISO 13485 solution.
We provide the best, most professional and comprehensive ISO 13485 consulting solutions available. Our consultants are qualified and practicing certification body auditors, highly experienced and knowledgeable and are committed to ensuring your project will be successful. More importantly, our unique approach ensures that we take most of the effort in the project and leave you with a solution that is meaningful, valuable and easy to maintain.
GUARANTEED SUCCESS. We are familiar with the ISO 13485 standard and confident about our capabilities that we guarantee in writing that you will be successful in your ISO assessment.
VALUE FOR MONEY. We are a small organization without substantial overhead. We spread payments over the full duration of the project.
ISO 13485 EXPERTS. Our consultants are fully employed, qualified ISO 13485 auditors, approved lead auditor lecturers and are called upon frequently to make ISO 13485 presentations at National venues.
ISO 13485 EXPERIENCE. In 25 years we have worked in most industries. Also, because of our wide experience we are particularly good at transferring applications to new or unique situations.
PROVEN APPROACH. Our unique approach ensures that everything gets done in way that we know will be successful. We have used our methodology for the past 25 years without failure.
MEANINGFUL SOLUTIONS. Our focus has always been on producing process based solutions that are valuable to our clients. You end up with an ISO 13485 system that is easy to maintain and is useful in your organization.
TURNKEY SOLUTIONS. We can provide complete consulting solutions including project planning, gap analysis, writing all documents, training, implementation support, assistance with registrar selection and guaranteeing success. We take the majority of the effort so you and your employees can stay focused on your jobs.
SPECIFIC ACTIVITIES. If you just need a document review, internal auditing, auditor training or any specific project activity we are able to provide individual, specific tasks too.