We are able to offer advice and support to medical device companies whatever their size.
Our range of services include:
Writing and updating technical documentation and design dossiers including:
procedures and advice for writing quality documents
commissions to write technical documentation
reviewing and preparing clinical evaluation reports to ensure compliance with MDD 93/42/EEC, MDR and ISO 13485
Writing and reviewing technical reports on biocompatibility, validation of sterilisation and software, gap analysis for the MDR
Our training sessions are tailored to clients’ specific needs and requirements – they reflect the size of the company and scope of its products and services. Training topics include MDD 93/42/EEC, MDR, risk management, clinical evaluation according to MEDDEV 2.7.1 rev4 and sterilisation by ETO/ irradiation/ steam/cleanroom.
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 includes a presentation of MDR requirements, the structure of MDR, conformity assessment routes, general safety and performance requirements, classification and clinical evaluation. The workshop is supported by an online trainer and includes skill practice sessions and tests. A certificate is delivered 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, ISO 9001:2015MDD 93/42/EEC, MDR and CMDCAS. We are also able to provide support during audits undertaken by notified bodies.
Use of MDSSPRO’s forms, documents and guides