AveniCom Quality and Regulatory (AVCQR) Templates are proven to be efficient and easy to understand. These templates were written by the quality and regulatory professionals with experience spanning emerging and established companies and have been successfully utilized to launch hundreds of medical device products (including IVDs) in the US, Canada, European Union, Asia, and other emerging markets. These templates support pre-market, post-market and infrastructure development for both manufactures and distributors.
Our templates provide a simple, straight-forward compliance solution that can be modified to fit your organization and grow with your business while being managed by single compliance professional. Our team offer systems and/or individual documents with options for simple to complex requirements that are the best fit for your business.
AVCQR provides a solid foundation for your internal documentation control systems and frees up resources to focus on your products and getting them to market faster.
Our Regulatory Affairs template documents are meant to serve as a guide that includes assists your company includes your niche or specific business requirements. We recommend that you reference the regulations and applicable guidance documents as you prepare your documents.
Our Quality Management System (QMS) templates can assist your company to build a baseline quality management system infrastructure that meets varied life science industry requirements.