© 2018 created by MDSSPRO

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 developing some documents ready to use for remediation to the non-conformities detected during an audit or a technical file/design dossier review by your notified body

 

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

 

LEARNING METHODS

You want to know more about the learning methods used and how they are taken into account in  our training materials? Then you are in the right section

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:

Merlin House
4 Meteor Way
Off Broom Way
Lee-on-the-Solent
PO13 9FU