MedTech Audits
By choosing Apotech for your MedTech auditing services, we can help you deliver complete regulatory compliance for all of your medical devices.
Optimising certification to offer complete compliance
Trust Apotech for your MedTech auditing requirements.
At Apotech, we specialise in helping you achieve certification for your MedTech products.
Our specialist team are expertly trained to ensure complete compliance with a myriad 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.
Our range of IVD auditing services
Our comprehensive range of auditing services can be tailored to suit your exact needs. Whether you require a remote audit, MDSAP audit or any other type of auditing service, we can match our approach to your device’s requirements, providing expert-led support at every step.
Why choose Apotech for auditing?
At Apotech, we understand just how important quality compliance is, especially within Medical Devices. That’s why our services are designed to streamline the complexities involved during your required auditing processes.
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 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 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.
We provide competitive pricing.
Our pricing model is competitive, providing you with professional MedTech auditing services that you can have 100% confidence in.
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…