Services
Our Services
Tailored Assistance for Medical Device Companies
We provide bespoke services to medical device companies, regardless of their size. We want compliance against the EU Medical Device Regulations (MDR 2017/745) to be straightforward, effective, and achievable for you and your business.
Whether you are launching a new product or simply revising your quality systems, our team delivers practical and accessible solutions that meet your business type, product categories, and regulatory requirements.
Training
We appreciate that not all medical device companies are the same, and that is why each training programme we deliver is tailored to your specific requirements. Sessions are tailored and shaped to the scale of your operations, types of devices produced, standards you have to comply with and your aspirations for the training programme
Our training will cover essential content on:
– The EU Medical Device Regulation (MDR 2017/745).
– Risk management and clinical evaluation as described within the MEDDEV 2.7.1 rev4 and MDR 2017/745 annex XIV .
– Sterilization methods using ETO, irradiation or steam.
– Cleanroom and contamination control procedures.
Workshops can be arranged for small teams (approximately 1 to 10 delegates) and can be delivered as short, focused one-day workshops or detailed week-long training programmes. Each will be tailored to ensure competence and a lasting understanding of regulation within your team.
E-Learning for MDR Compliance
We are pleased to offer an easy-to-use and interactive method to learn through our online MDR training courses. The training we provide is designed to help you navigate the new regulation’s structure, technical documentation requirements, quality system requirements, and notified body processes.
Each course is designed with a combination of live online delivery of content, interactive exercises, and short assessments to confirm understanding. Learners will receive full support from a qualified trainer during the course and will receive a certificate of completion when all course content is completed.
Auditing Services
With over 20 years of experience, our auditing experts provide practical expertise and precision to every project. We perform internal and supplier audits to assist companies in identifying gaps, enhancing systems, and achieving major compliance levels to international standards.
Our audits can be performed on:
- ISO 13485:2016
- ISO 9001:2015
- MDD 93/42/EEC
- MDR 2017/745
- MDSAP
- We can also support you during an external audit that has been conducted by your notified body, and we will support you without hesitation to prepare the necessary documentation and respond to findings or observations
Partner With Us For Compliance Success
At MDSSPRO, compliance should foster innovation rather than restrict it. With practical training, professional auditing, and continuous support, our team will assist your organisation in achieving every regulatory requirement with confidence.
