IVD Audits
Ensure complete regulatory compliance of your in vitro diagnostic (IVD) products by choosing Apotech for your IVD auditing services.
Streamlining certification and regulatory compliance
Choose Apotech for your Audit needs.
At Apotech, we can help you achieve certification for your IVD products.
Our team are highly experienced and trained to ensure compliance with a wide range of global regulations, including ISO 13485, the U.S. Food and Drug Administration’s (FDA’s) QMSR, European Medical Device Directives and Regulations and the Medical Device Single Audit Program (MDSAP).
Trusted by top-tier teams worldwide
In addition to ISO 13485, FDA, and MDR/IVDR audits, we offer targeted audits against a wide range of international quality and information standards.
We support audits for:
ISO 27001 – Information Security:
We audit your Information Security Management System (ISMS) to help identify and address data protection gaps. ISO 27001 is key to building a resilient cybersecurity posture.
ISO 9001 – Quality Management:
We help organisations prepare for or maintain ISO 9001 certification by auditing QMS performance, documentation, and continuous improvement measures.
ISO 62304 – Software Lifecycle:
For software as a medical device (SaMD), we audit your software lifecycle processes in line with ISO 62304. Our audits ensure your development, maintenance and risk processes are compliant with regulatory expectations.
Why choose Apotech for Auditing?
Whether you’re in need of an internal audit, supplier QMS audit or an audit against standards including ISO 13485, QMSR, MDSAP or ISO 9001, we can work with you to ensure complete device compliance.
We recognise the importance of ensuring quality compliance. That’s why we have designed our services to help you navigate the complexities involved during the auditing processes you are required to carry out.
We offer a global reach.
With consultants available in every major global country, we can provide tailored advice and guidance to represent you wherever you’re based.
We provide competitive pricing.
Our pricing model is competitive, providing you with professional IVD auditing services that you can have 100% confidence in.
We speak your language.
Whichever market you are looking to enter, our consultants operate in a number of countries and can communicate with you in your local language.
Featured case studies
Prosthesis manufacturer
Prosthesis manufacturer Introduction As part of their international development strategy, our client wanted to get MDSAP certified with a focus on Canada, Australia and Brazil. They were MDSAP certified within 7 months. Types MDSAP Audit Preparation, Quality Management System Review Scope of work Selecting the certification body (quotes, Q&A) Review of their quality management system…
Quarterly Internal Audits
Quarterly Internal Audits Introduction Quarterly Internal Audits Our client is a start-up medical device manufacturer of a body cooling device, for those with heat stroke. They are based in the UK and are undergoing ISO 13485 certification. Standards & Tools 21 CFR ISO 13485 MDSAP MDR Scope of work Key numbers Excited to work together…