IVD Audits

Supplier QMS audits

At Apotech, our supplier or subcontractor audits meticulously evaluate external partners against industry standards. 

We can efficiently assess distributors, suppliers, manufacturers and other collaborators to ensure complete compliance, taking a streamlined approach that empowers you to make more informed decisions, strengthen relationships and optimise your third-party performance.

MDSAP internal audits

MDSAP is recognised across key medical device markets such as the United States, Canada, Brazil, Australia and Japan. 

Our comprehensive MDSAP audits not only identify areas for improvement but also ensure that your organisation is well-prepared for MDSAP certification. This is a crucial step for navigating the complexities of international medical device regulations and gaining market access in multiple jurisdictions.

FDA QSIT (mock) audits

The FDA Quality System Inspection Technique (QSIT) audit is indispensable for US market compliance, focusing on critical quality system components.

At Apotech, our FDA QSIT audits closely emulate real assessments, examining your quality management system to align with the FDA's specific framework. 

Our team of adept auditors, equipped with technical expertise and a demonstrable track record, will thoroughly evaluate key elements such as design controls and corrective actions.

Through this tailored approach, we can then identify areas for improvement and prepare your organisation for the real FDA inspections, helping you navigate US regulatory requirements seamlessly.

Remote or desktop audits

Our remote audit capabilities cover a wide range of quality standards, including ISO 13485 and FDA audits, to ensure your organisation remains compliant and up-to-date with regulatory requirements. 

Whether you're seeking certification, preparing for regulatory inspections or looking to enhance your quality management systems, our experienced team of ex-notified body and lead auditors are here to support you every step of the way. 

With our remote audit services, you can access expert guidance and assessment from anywhere, saving time and resources while maintaining the highest standards of quality and compliance. 

Additional auditing services

Our team can also provide a wide range of additional auditing services, such as internal audits, pre-certification audits, certification audits and flexible remote or desktop audits, to meet the following international standards:

• ISO 27001

Apotech can provide auditing support against ISO 27001 – an international standard for information security management systems (ISMS) that provides a systematic approach to managing sensitive company information. 

With cybercrime on the rise and new threats constantly emerging, it can often seem difficult or even impossible to manage cyber risks. However, our team can provide comprehensive audits of ISO/IEC 27001 to help your organisation become proactively identify and address weaknesses.

Additional auditing services

Our team can also provide a wide range of additional auditing services, such as internal audits, pre-certification audits, certification audits and flexible remote or desktop audits, to meet the following international standards:

• ISO 9001

As one of the most widely recognised quality management standards globally, ISO 9001 provides a framework for organisations to demonstrate their ability to consistently provide products and services that meet customer and regulatory requirements. 

Our team of expert auditors can provide valuable assistance to organisations either seeking to achieve ISO 9001 certification or aiming to maintain compliance with the standard.

Additional auditing services

Our team can also provide a wide range of additional auditing services, such as internal audits, pre-certification audits, certification audits and flexible remote or desktop audits, to meet the following international standards:

• ISO 13485

ISO 13485 is an international standard that specifies requirements for a quality management system (QMS) for medical devices. It outlines the criteria for organisations involved in the design, development, production, installation and servicing of medical devices to ensure compliance with regulatory requirements and consistently meet customer and applicable regulatory requirements. 

Our team can provide ongoing expertise and guidance to ensure that your ISO 13485 audit process remains thorough, compliant and effective, by offering insights into best practices and regulatory requirements and identifying opportunities for improvement within the medical device quality management system.

Additional auditing services

Our team can also provide a wide range of additional auditing services, such as internal audits, pre-certification audits, certification audits and flexible remote or desktop audits, to meet the following international standards:

• ISO 62304

  Our team can also provide auditing support against ISO 62304 – an international standard that specifically addresses the software lifecycle processes for medical device software. 

  Working with the guidelines set by this standard for the development, maintenance and risk management of medical device software throughout its entire lifecycle, our consultants can provide you with valuable assistance and help ensure your medical device software delivers complete compliance.