Quality Systems and Compliance
From start-ups to larger global organisations, our experienced team at Apotech helps MedTech companies of all shapes and sizes improve the quality and compliance of their products.
Practical solutions designed to deliver results
Adopt a risk-based approach to improve your quality and compliance.
At Apotech, our experienced consultants can help you improve the quality and compliance of your MedTech products. By taking a risk-based approach, we can help design and implement practical solutions that are proven to deliver results.
Adopting this scalable approach is also what allows us to work effectively with a wide range of companies – from research and development-stage start-ups to small and medium enterprises and much larger global organisations.
Trusted by top-tier teams worldwide
ISO 13485
At Apotech, we specialise in guiding companies through the development and maintenance of ISO 13485 compliant quality management systems (QMS). Our experienced team employs a systematic approach, assisting in the establishment of robust processes aligned with ISO 13485 requirements.
We tailor our services to address your specific needs, ensuring that every aspect of your QMS meets the international standards for medical device quality. Beyond initial implementation, we provide ongoing support to maintain and continually improve your QMS, offering comprehensive audits, training and strategic insights.
With Apotech by your side, building and sustaining an ISO 13485 compliant QMS becomes a streamlined and effective process, contributing to the overall success and regulatory excellence of your medical device operations.
Our ISO 13485 services include:
- Gap analysis
- QMS remediation
- QMS implementation
- CAPA
- Root causes analysis
- Internal audit
- QMS maintenance
Our team also specialise in tailoring your ISO 13485 quality system to align with your unique requirements and ensure its readiness for a certification audit. Our collaborative approach involves closely coordinating with the ISO 13485 consulting and project management teams to implement your QMS both efficiently and within budget.
We can also offer guidance on reputable third-party testing and certification firms, specifically chosen to match your device category, to improve the overall effectiveness and compliance of your quality system.
Design and Development File
In the EU, a similar requirement is stated as the Design & Development File (DDF) in ISO 13485 – the harmonised standard for the quality management system for medical devices. This DDF should collate all evidence for conformity to the regulation in regard to design and development including its changes.
The DDF contains comprehensive documentation of the design and development process, ensuring conformity with regulatory requirements outlined in the Medical Device Regulation (MDR) or the In Vitro Diagnostic Regulation (IVDR).
It serves as a structured compilation of records and documentation related to the design and development of a medical device, providing evidence of conformity with essential requirements. This includes factors like safety, performance and usability throughout the product lifecycle.
We can provide support in the following areas:
- Design controls implementation
- Risk management
- Usability engineering
- Traceability
- Verification and validation
- Design changes
FDA
21 CFR PART 820- QSR (QUALITY SYSTEM REGULATION) / QMSR (QUALITY MANAGEMENT SYSTEM REGULATION)
[Please be aware that you have up to 2026 to be compliant with QMSR!]
If you are looking to market your medical devices in the US, you will need to demonstrate compliance with the Food and Drug Administration (FDA) Quality Management System Regulation (QMSR), outlined in 21 CFR Part 820.
The FDA plays a pivotal role in overseeing the distribution of medical devices across the country, ensuring that devices available in the USA meet stringent safety and effectiveness criteria. Adherence to the comprehensive QMSR outlined in 21 CFR Part 820 is mandatory for all medical device manufacturers aiming to commercialise their products in the US.
Therefore, these regulations are designed to not only guarantee the safety and efficacy of medical devices used in clinical settings but also encompass all the fundamental requirements and other legal obligations imposed on MedTech manufacturers.
Our team at Apotech can support you with ensuring QMSR compliance in various ways:
- Compliance assessment: We can evaluate your existing processes against FDA QMSR, identifying any potential gaps.
- Gap analysis and remediation: Our consultants can conduct a gap analysis and offer remediation plans for FDA QMSR compliance to ensure a clear path to alignment.
- QMS implementation: We can guide the implementation of an effective QMS aligned with FDA QMSR.
- Audits and inspections: We can conduct internal and supplier audits, prepare for FDA inspections and ensure ongoing compliance.
- Continuous monitoring: By establishing mechanisms for continuous compliance monitoring, we can adapt to changes and address any potential challenges.
- Regulatory updates: We can keep you informed about any changes to FDA regulations or industry trends to deliver ongoing compliance.
Device History Record (DHR)
After the completion of manufacturing, each control step and inspection must be recorded in accordance with 21 CFR 820.184. These records are compiled into the Device History Record (DHR), which serves as a comprehensive repository of all pertinent information.
The DHR not only demonstrates compliance with specifications but also encapsulates all manufacturing data essential for confirming consistent quality characteristics.
In the EU, ISO 13485 mandates the retention of manufacturing data and lot release records, constituting the lot record per batch. This record, synonymous with the US requirements, provides a thorough account of each lot's manufacturing details and ensures adherence to quality standards.
At Apotech, we can provide support in the following areas:
DHR build
- Manufacturing details
- Distribution
- Traceability
- UDI/UPC
- Monitoring and measurement
- Verification and validation
- Primary identification label
- Acceptance/inspection records
- Storage and handling
- Product realisation
Device Master Record (DMR)
The Device Master Record (DMR) is a comprehensive document maintained by medical device manufacturers to provide specifications and instructions for the production of each device.
Under the FDA's Quality System Regulation (QSR), the DMR contains all the necessary information and records related to the design, production, testing, packaging, labelling and quality assurance of the medical device.
It includes specifications for materials, components, processes, equipment, and procedures used in manufacturing, as well as documentation of design changes, device history records, labelling instructions and quality control measures.
At Apotech, we can support you in developing, organising and maintaining the DMR to ensure compliance with FDA regulations and quality standards. This may involve:
- Reviewing and updating existing documentation
- Implementing standardised processes and procedures
- Conducting gap assessments
- Providing training on regulatory requirements
- Facilitating communication with regulatory authorities
MDSAP
MDSAP enables medical device manufacturers to undergo a single audit, satisfying the quality requirements of key markets, including the US, Canada, Australia, Brazil and Japan. Receiving its certification offers three key benefits: it ensures efficient compliance, reduces any associated burdens and facilitates your global presence.
Our support ensures your quality management system seamlessly aligns with MDSAP standards, streamlining audits and facilitating market access.
We start this process by assessing your current level of MDSAP compliance using an initial MDSAP gap analysis, either targeting all of the MDSAP countries or only some of them.
Employing the same methodology as auditing organisations (AO), we allow for strategic planning and implementation of corrective actions, pedagogically preparing you for the nuances of an official AO certification audit. The gap analysis then culminates in a transition planning session.
After this session, we will then provide you with a comprehensive written audit detailing our findings and a practical roadmap to address any of these. From these insights, you can then comprehensively and effectively prepare your company for MDSAP certification.
Our MDSAP services cover:
- Initial gap assessment
- MDSAP implementation
- Mock inspection
- MDSAP training
- Approved bodies relationship
ISO 14971 – Risk Management
Integrating ISO 14971 into your quality management system is essential for several reasons. Not only does it help proactively identify design issues, but it also helps prevent hazardous problems and reduces the costs associated with recalls.
At Apotech, we have the expertise required to efficiently implement ISO 14971 processes and offer an external perspective on your risk management practices.
We aim to help you establish, document and maintain a robust risk management process by reviewing device use, identifying potential hazards, estimating harm probability and severity, and implementing effective controls.
Once we have these insights available, we can provide you with the most modern and efficient tools to manage your risk assessment. In fact, we can even implement and run interactive risk management workshops to help you and your team learn more easily.
Our ISO 14971:2019 services cover:
- ISO 14971 implementation
- Risk management tools implementation
- Risk management workshop
- Risk-benefits analysis
- Audit of risk management processes
Training
Your company’s efficiency and reliability rests on the expertise and knowledge of your employees. So training them in the right way is vital to meeting the standards set by international regulatory bodies.
In order to succeed, your chosen training provider must possess a deep understanding of the medical device sector, proficiency in developing impactful training programs and a comprehensive array of courses in their portfolio. At Apotech, we have all three.
- Private training: If you require group training, we can deliver the class as-is or tailor it to suit the specific needs of your employees.
- Online training: A perfect alternative to traditional classroom settings, online training is particularly suitable for quality and regulatory professionals who cannot travel or prefer the convenience of attending classes from the comfort of their own homes.
- Training program development: Our training professionals are ready to help your organisation assess your training needs, develop or update your RA/QA curriculum and design and teach pilot courses. Your organisation retains ownership of the training assets, and we are committed to assisting you in their improvement and updating.
Gap Analysis
Our experienced consultants can also provide expert evaluation and analyses to bridge any regulatory or quality compliance gaps.
After conducting a precise gap assessment, we can then use our experience to align your operations with crucial standards and abide by various regulatory guidelines. These include:
- FDA 21 CFR Part 820 QSR/QMSR
- ISO 13485
- ISO 9001
- MDR 2017/745
- MDSAP
- Global
Why choose Apotech’s quality systems and compliance services?
Whether you need help in developing or maintaining your ISO 13485:2016, MDSAP or FDA CFR QSR / QMSR, we can help.
Thanks to our consultants’ in-house experience, we have all the training and expertise required to provide you with a high level of regulatory support and guidance, allowing you to enter into new markets with complete confidence.
Our range of quality systems and compliance services
At Apotech, our experienced consultants are ready to support you in all of your service needs.
We can help you not only establish and enhance robust quality management systems but we can also conduct thorough audits to guarantee the safety and efficacy of your medical devices.
FAQs on quality systems and compliance
We recognise that the world of quality systems and compliance can be fairly confusing at times. That’s why we aim to make the process as easy to understand as possible by being completely transparent about our services.
Here are some of the questions we are asked most often.
ISO 13485 was introduced in 1996, which happens to be the last time a major update to 21 CFR Part 820 (QSR) occurred. Since that time, ISO 13485 has been modified a few times, and the most recent version – ISO 13485 – is very similar to FDA QSR.
The FDA says it is now time to harmonise the two by replacing the QSR with the QMSR. The primary change here is that Subpart A of the new proposed QMSR refers to ISO 13485 as the basis for compliance with the QMSR but with some minor modifications as discussed below.
This means that all companies required to comply with the QMSR will essentially be following ISO 13485 even if not certified by a third party. Where differences exist between ISO 13485, the Food, Drug, and Cosmetic Act (FD&C Act) and QMSR, the QMSR will prevail.