Medidas® is a boutique regulatory advisory experienced in resolving quality & regulatory medical technology product related issues & problems. Our focus is on small-medium (SME) medical device companies, substance-based products and products without medical/therapeutic claims. Our activities include:
- resolving regulatory-quality scientific-technical problems & isues manufacturers, importers & distributors face;
- looking for & implementing practical realistic solutions to those issues; and
- increasing regulatory awareness in helping create a corporate culture of compliance in quality & regulatory areas by developing & publishing quality-regulatory materials. These materials can be found under the header “Publications”.
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.
Activities
Developing & generating techical document expert reports including but not limited to:
- Clinical evaluation reports (CER) for medical devices in compliance with prevailing regulations and guidance;
- Biological safety evaluation reports (BER) to prevailing EN ISO 10993:2018;
- Risk assessment & risk benefit analysis (RBA) to prevailing EN ISO 14971:2019;
- Safety assessment reports for products without medical claims;
- Product information files for products with non-medical claims;
- Post-market data reports / Periodic user reports for medical device.
Regulatory advice on implementing & applying rules & regulations including quality system requirements for medical devices.
Act as person responsible for regulatory compliance (PPRC) under §15 MDR 2017/745 for European device manufacturers & authorised representatives.
Ordering Publications
Publications & materials listed in this section 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
Get ready for 26 May 2021 by understanding design control under the new regulations.
Synopsis: This authoritative publication sets out a practical roadmap for implementing and applying good design practice for medical devices in particular under the MDR 207/745 & EN ISO 13485:2016 medical device requirements. It clarifies the steps of the design & development process from input to transfer through a practical road-map. The roadmap clarifies each phase of the R&D process with practical tips & advise. Includes an interpretative and annotated reference guide bringing together quality and regulatory requirements under the MDR 2017/745. This roadmap is a must for any engineers, regulatory and quality professional and senior management involved with design & development of medical technology products.
- Price EU: € 35 excluding VAT/BTW
- Shipping within the Netherlands: € 3.95