Medical Device Software and Sterilisation Professionals (MDSSPRO) helps companies understand, manage and implement Medical Device Regulation (MDR)
Our consultancy services focus on the preparation of high-quality technical documentation and design dossiers and include:
- Advice and procedures to follow when writing documents
- writing technical documentation / Design dossier for compliance with MDR 2017/745
- Reviewing and preparing clinical evaluation reports to ensure
compliance with MEDDEV 2.7.1 rev 4, MDR and ISO 13485
- Writing and reviewing technical reports on biocompatibility, validation of sterilisation and software, gap analysis
- writing PMCF protocol & report and implementing PMCF study
- statistical analysis of clinical data
Our training courses are tailored to clients’ specific needs and requirements – they reflect the size of the company and scope of its products and services.
On-site training sessions, typically for one to ten delegates range from two days workshops to week long programmes
New MDR e-learning
We are now able to offer clients interactive e-learning training workshops which include a presentation of MDR requirements, the structure of MDR, conformity assessment routes, general safety and performance requirements, classification and clinical evaluation. Workshops are supported by an online trainer and include skill practice sessions and tests. A certificate is presented at the end of the training.
Our team of MDR internal auditors have over 20 years’ experience auditing medical device companies. Our work covers internal and supplier compliance audits
according to ISO 13485:2016, MDD 93/42/EEC, MDR and CMDCAS. We are also able to provide support during audits undertaken by notified bodies.
MDSSPRO is a market-leading MDR consultancy and prides itself on helping clients achieve and maintain relevant product and service certification.
Book now your audit online
We are providing the medical device manufacturers with the latest publications on medical device regulation and its application. This week: publications on the UDI database and new training available on IEC 60601-1
For further information about our products and services or a general chat about how we may be able to help your business, please contact us on:
4 Meteor Way
Off Broom Way