A customized Quality Management System designed to scale with you, no matter the stage of your product life cycle.
get started
Whether you are developing a traditional medical device or software-only, we can help build a customized QMS that suits your company and the products you develop while maintaining compliance to FDA, ISO 13485, and other international requirements.
While we can help support and implement a usability program to enable compliance, like IEC 62366, we ultimately ensure your customers wants and needs are met. Our expertise in product development, quality and regulatory ensures that we help you think about your user needs as well as comply with standards and relevant guidelines.
Whether or not you need real clinical data for your submission is an important question to resolve. We can help you determine what those clinical data requirements are, as well as, help develop your clinical study plan and protocols.
Whether or not you need real clinical data for your submission is an important question to resolve. We can help you determine what those clinical data requirements are, as well as, help develop your clinical study plan and protocols.
Timeline varies depending on size of company & resources available.
Review company structure, resources, policies, tools.
Perform a gap analysis in order to determine how to customize your QMS.
Create quality manual and quality procedures
Support creating the records to show you that you are complying to your custom-built QMS
Training is provided
A 3rd party audit to confirm that you are complying to your QMS
Bi-weekly review of your QMS to ensure you are continuously complying to your QMS
Review company structure, resources, policies, tools.
Perform a gap analysis in order to determine how to customize your QMS.
Create quality manual and quality procedures
Support creating the records to show you that you are complying to your custom-built QMS
Training is provided
Create quality manual and quality procedures
Bi-weekly review of your QMS to ensure you are continuously complying to your QMS
The size of your company, resources and capital will depend on what QMS will be right for you. Whether you are a startup or a mid-larger sized company, we help you build a scalable QMS that will allow you to only pay for what you need now and will grow with you later.
Our approach takes into account international regulations and standards so that you can be assured that your quality management system is ready for international growth if you decide to expand.
Adhering to the QMS is a responsibility for everyone in the company. We help you identify the key players responsible for establishing your policy & its objectives and identifying the managers and team members responsible for carrying out these objectives.
When it comes to outsourcing manufactures, it is important to understand that you cannot outsource compliance. Meaning, the manufacturers must uphold the QMS you have implemented in order to ensure your products quality system is properly enforced.
Not only are we able to integrate a comprehensive regulatory and quality system, we take a thoughtful approach to set you up to maintain your processes.
contact us
