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QMSR key changes affecting FDA inspections for medical device quality systems

QMSR key changes explained: what FDA inspections will now expect

QMSR key changes have been discussed in the medical device industry for years. Most QA/RA professionals are already familiar with the headline: FDA is aligning 21 CFR Part 820 with ISO 13485:2016. What is QMSR? The Quality Management System Regulation (QMSR) is FDA’s amended quality… 

What auditors expect from approval workflows under ISO 13485 and FDA quality system requirements

What Auditors Expect from Approval Workflows (ISO 13485 & FDA)

Approval Workflows are often treated as a final checkbox.In reality, they’re one of the first places auditors look when assessing how decisions are made inside your QMS. Auditors don’t review approvals in isolation.They examine the structure behind them — roles, sequence, versions, rationale, and traceability.… 

A vibrant galaxy background featuring a large yellow triangular warning icon with an exclamation mark, representing smarter medical device risk management and ISO 14971 compliance.

How Companies Are Transforming Their Risk Assessment Processes for Better Results

Optimizing Medical Device Risk Management for Efficiency, Accuracy, and Compliance One of the persistent challenges in medical device development is ensuring that risk assessment processes are both compliant and practically useful. While standards like ISO 14971 provide the framework, implementation in real-world scenarios often reveals inefficiencies —… 

A small, friendly-looking white robot positioned against a vibrant, deep-space galaxy background with stars and nebulae, representing AI-assisted medical device development.

How to Apply AI Risk Prompts to Real-World Medical Device Development

Effective risk assessment is a foundation of compliant and safe medical device development. If you’ve downloaded our free guide with expert-level ChatGPT prompts, you’ve already made a strategic move toward improving your risk management processes. Now it’s time to translate those AI-generated insights into practical, real-world actions — grounded… 

ISO 9001 implementation: Mandatory documents and records Mandatory documents and records when it comes to the ISO 13485 implementation are previously discussed. It is turned to discuss the same regarding ISO 9001:2015 implementation. These are the documents to produce in order to be compliant with ISO 9001:2015: 4. Context of the organization Clause 4.3: Scope of the QMS 5. Leadership Clause 5.2: Quality policy 6. Planning Clause 6.2: Quality objectives 8. Operation Clause 8.4.1: Criteria for evaluation and selection of suppliers And, these are the mandatory records: 7. Support Clause 7.1.5.1: Monitoring and measuring equipment calibration records Clause 7.2: Records of training, skills, experience and qualifications 8. Operation Clause 8.2.3.2: Product/service requirements review records Clause 8.3.2: Record about design and development outputs review Clause 8.3.3: Records about design and development inputs Clause 8.3.4: Records of design and development controls Clause 8.3.5: Records of design and development outputs Clause 8.3.6: Design and development changes records Clause 8.5.1: Characteristics of product to be produced and service to be provided Clause 8.5.3: Records about customer property Clause 8.5.6: Production/service provision change control records Clause 8.6: Record of conformity of product/service with acceptance criteria Clause 8.7.2: Record of nonconforming outputs 9. Performance evaluation Clause 9.1.1: Monitoring and measurement results Clause 9.2: Internal audit program Clause 9.2: Results of internal audits Clause 9.3: Results of the management review 10. Improvement Clause 10.1: Results of corrective actions Please note that some of the documents and records won’t be mandatory if the company doesn’t perform relevant processes. Non-mandatory documents: There are numerous non-mandatory documents that can be used for ISO 9001 implementation. So, these are not mandatory, but commonly used in organizations: 4. Context of the organization Clauses 4.1 and 4.2: Procedure for determining the context of the organization and interested parties 6. Planning Clause 6.1: Procedure for addressing risks and opportunities 7. Support Clauses 7.1.2, 7.2, and 7.3: Procedure for competence, training, and awareness Clause 7.1.5: Procedure for equipment maintenance and measuring equipment Clause 7.5: Procedure for document and record control 8. Operation Clause 8.2: Sales procedure Clause 8.3: Procedure for design and development Clause 8.5: Procedure for production and service provision Clause 8.5.4: Warehousing procedure Clauses 8.7 and 10.2: Procedure for management of nonconformities and corrective actions 9. Performance evaluation Clause 9.1.2: Procedure for monitoring customer satisfaction Clause 9.2: Procedure for internal audit Clause 9.3: Procedure for management review A well-structured document system guarantees quality standard is met, reduces the possible errors, reduces downtime when deviations occur due to being able to rapidly access relevant data and allows easy monitoring of the processes. It will improve the organization’s efficiency ensuring that its QMS has a strong foundation.

ISO 9001 implementation: Mandatory documents and records

Mandatory documents and records when it comes to the ISO 13485 implementation are previously discussed. It is turned to discuss the same regarding ISO 9001:2015 implementation. These are the documents to produce in order to be compliant with ISO 9001:2015: 4. Context of the organization 5. Leadership… 

A smiling man holding several paper documents against a green-toned background, representing the successful organization of mandatory ISO 13485:2016 records and files.

ISO 13485 implementation: Mandatory documents and records

Preparation of the QMS documentation is based on the organizational needs, and it is crucial for an efficient QMS. Besides, correctly organized documentation will make operations much easier. The purpose of QMS documentation is to provide a clear framework for the company’s operations and a better understanding of… 

Digital illustration of a laptop showing "Healthy Heart" text alongside human anatomical diagrams, representing the software life cycle for Software as a Medical Device (SaMD) under EN 62304.

Software as a medical device – life cycle

The life cycle of the medical device is a development process of the product, from its beginning to the end. The same applies to software that can represent a medical device (SaMD) or a medical device that has software as its part. Establishing the security and efficiency of such products requires… 

Tablet screen displaying the qmsWrapper eQMS dashboard with a prominent blue validation checkmark, illustrating software validated for ISO 13485 and 21 CFR Part 11 compliance.

Validation efforts

When an eQMS is implemented in a medical device company, such software must be validated.  It should be ensured that the system is working and that it meets the requirements of ISO 13485. Validating the software decreases risk and legal liability, and provides evidence that the…