Annette Callaghan Limited

Quality Management Consultants for the Healthcare Industry.

Annette Callaghan has been involved in medical device and pharmaceutical manufacturing, quality and regulatory affairs for over 30 years. Annette Callaghan Limited and Annette Callaghan (Ireland) Limited specialise in helping small to medium-sized medical device and pharmaceutical companies meet the ever-growing challenge of regulatory compliance.

Whether you need help with your quality system, internal auditing, supplier auditing, training or just generally keeping up to date, we offer a personal service to give you peace of mind. Contact Annette Callaghan Limited today to see how we can help.

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Medical Device Quality Management Systems

including CE marking, ISO 13485:2016, 21CFR 820, MDSAP…

Training for the Healthcare Industry

Internal auditor, QMS/PQS implementation, Technical File creation, GMDP and related topics

European and UK Authorised Representative Service

Your regulatory presence in the EU and the UK

Qualified Person and Responsible Person Services for GMDP

API audits, GMDP audits, QP under permanent provisions, contract RP services

Medical Device Regulatory Compliance

Are you ready for EN ISO 13485:2016? We can help…

Struggling to understand the new European Medical Device Regulations? We can help…

Are you behind schedule with your internal audits? We can help…

Training

Are you fed up with long, overly complicated and irrelevant training courses? We can help…

Do you have a limited training budget? We can help….

Are you an experienced manager, but new to the medical device industry? We can help….

Our Blogs

Keep up to date with our latest blogs and industry news. We aim to bring you the latest information from the industry, right here on our website.

13-11-19Updated MHRA Guidance on Clinical Trials

The MHRA updated their guidance regarding notification of clinical investigations for medical devices on 1st October 2019. The updated guidance ...

13-11-19And BSI makes 7

We now have seven Notified Bodies designated under Regulation (EU) 2017/745 on medical devices, the newest of which is BSI Netherlands, ...

3-9-19And then there were 4

So now we have 4 Notified Bodies designated under EU MDR. Unfortunately, one of these, BSI Assurance, is located in ...

Contact Us

Got a question you’d like to ask or want to enquire more about our services, then please use the contact form below to send us an e-mail.