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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).
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Trusted by top-tier teams worldwide
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Internal audits
Internal audits are a strategic examination of your quality management system (QMS) against relevant standards such as ISO 13485.
Our experienced team – comprised of ex-notified body or, at minimum, lead auditors – can ensure a thorough evaluation to identify areas for improvement. With a focus on efficiency, our internal audits provide actionable insights, guiding your organisation towards a robust quality management system that’s always improving.
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:
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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.
Excited to work together on your next project?
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.
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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.
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We provide competitive pricing.
Our pricing model is competitive, providing you with professional IVD auditing services that you can have 100% confidence in.
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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 Global API Manufacturer 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 Client quote Apotech’s guidance in navigating the MDSAP audit…
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…