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.
Our mission
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.
Main Activities
Regulatory advice on rules & regulations governing medical devices, biologics, health products (cosmetics).
Support R&D efforts by implementing good design practice requirements resulting in finished products that are safe & effective.
Support quality system development & compliance efforts (e.g. US FDA QSR requirements, EN ISO 13485:2016, ISO 9001:2015, EU’s MDR 2017/745 requirements).
Act as person responsible for regulatory compliance (PPRC) under §15 MDR 2017/745 for European device manufacturers.
Generate high-quality scientifically valid technical documents to support pre-market approval process for medical devices. Including but not limited to:
- Clinical evaluation reports for medical devices
- Clinical trial documents
- Biological safety evaluation reports
- Risk assessment & risk benefit analysis
- Safety assessment reports
- Product information files for cosmetics
- Post-market data reports / Periodic user reports for medical devices
Ordering Publications
Publications can be ordered by sending the following information per e-mail to medidas@medidas.nl
- full contact details (name, address, e-mail and telephone) of person or entity ordering;
- full shipping details/address if different than person or entity ordering;
- VAT-identification when orders are placed by a company; and
- title and quantities required.
Orders received will be confirmed by e-mail including an invoice. The invoice must be paid prior to the order being shipped.
Available Titles
E. Nikkelen, et. al., Roadmap for Good Design Practice: Closing the gap between design & regulation. November 2019. ISBN 978-90-78027-157
Pages: 236 pages
Synopsis: This authoritative publication sets out a practical roadmap for implementing and applying good design practice for medical devices. It clarifies the steps of the design & development process from inputs to transfer. The roadmap helps clarify when a requirement is not a requirement; when design testing is not verification testing; when design controls are applicable; and so forth. Full of practical tips, it helps clarify and better understand the design & development process under the medical device regulations and EN ISO 13485:2016 & US FDA QSR requirements. The second part of the roadmap is an interpretative and annotated reference guide bringing together quality and regulatory requirements under the MDR 2017/745. The roadmap is intended for engineers, regulatory and quality professioanls and management of companies involved with design & development of medical technology products.
- Price EU: € 35 excluding VAT/BTW
- Shipping within the Netherlands: € 3.95