As an experienced professional in the medical industry, I started my own business with the goal of providing customized regulatory affairs support and quality solutions for start-ups and small to medium-sized companies. 
Product designers and developers face nowadays many obstacles implementing new medical regulatory requirements in their Quality Systems. It is difficult to streamline the right strategy required in the submission process to obtain product approvals or registrations, and it is almost impossible to predict deadlines. 
Lack of understanding of the steps in the structured process and the right alignment with requirements create delays to bring product into the market.
There is not a magical formula that fits all types of organizations, but there are alternatives to take advantage, facilitate, and speed-up the process. 
I conduct internal independent audits to find gaps and create solutions to meet  minimum regulatory requirements and demonstrate conformance to internal and external policies. 
My main purpose is to provide expertise and share my own ideas to build a solid infrastructure in manufacturing and enable the launch of products in a expedited fashion.