Medidas® is a boutique regulatory advisory experienced in resolving quality & regulatory medical technology product related issues & problems. Our focus is on:
- resolving regulatory-quality scientific-technical problems & isues manufacturers, importers & distributors face;
- looking for & implementing practical realistic solutions to those issues;
- increasing regulatory awareness of Medical Device Regulations (2017/745, 2017/746) to help create a corporate culture of compliance in quality & regulatory areas.
We support small-medium (SME) & start-up companies developing, manufacturing & commercialising medical devices or biologics or substance-based products with & without medical/therapeutic claims.
Additionally, Medidas® provides quality-regulatory technical support in terms of publications and supporting materials concerning medical devices. These publications are developed by medical device experts with a primary focus on providing medical device companies & regulatory-quality professionals with understanding medical device regulations & quality system requirements. The publications are intended for those professionals involved in medical device development, regulatory, quality and management. Current available list of materials are found under the header “Publications” along with pricing and ordering instructions.
We strive to provide high quality regulatory – quality expertise, personalised service, a no-nonsense practice approach, flexible scheduling & innovative solutions for regulatory-quality-business issues & problems. We strive to translate regulatory & quality requirements to identify the business benefit of regulatory compliance in an increasingly complex & regulated marketplace.