We are customer focused and totally committed in meeting our customer expectations and deliverables.

QAEC Limited can offer technical guidance on CE marking requirements and regulatory strategies leading to the commercialisation of new products.

The implementation of Quality Management Systems meeting the requirements of 21 CFR Part 820, the Medical Devices Directive 93/42/EEC transition to EU MDR 2017/745 and EU MDR 2017/746.

Transition to MDSAP (Medical Device Single Audit Programme) and ISO 9001: 2015 transition to
13485: 2016.

QAEC Limited also provide training in these areas and has worked with companies ranging from start-up companies, including University Spin-Off Projects to multi-national market leaders.

QAEC Limited can carry out quality and regulatory compliance audits, vendor audits, gap analysis, for medical device and pharmaceutical manufacturers.

QAEC Limited can assist in the preparation and review of Technical Files (Medical Device Files) also against the new MDR and Design Dossiers and assist in compliance issues related to sterilisation and microbiological control of production as applicable.