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Worry-Free Medical Device Software (SAMD) Compliance

Achieve FDA & ISO Compliance for Medical Device Software, QMS, and Manufacturing Systems.

Medical device compliance consulting for Biotech, Pharma, Biopharm, MedLab, Biomed, and R&D companies

Failure to meet regulatory standards can be costly

Failing to meet regulatory standards puts the success of your medical device at risk. You face expensive recalls, legal penalties, and delayed launches... impacting your company's trust and bottom line.

You're not sure how to comply.

Your people are too busy to figure out compliance.

You don't trust your documentation and systems to meet compliance standards.

Audit-Ready Software Validation & Compliance

Remediate, Validate, and Comply

Medtech SW Compliance Analyzer

Easily identify the gaps in your Medical Device's compliance: Classified by Risk, Validation, or QMS.

All-in-One QMS Tune-Up

Your Quality Management System (QMS) is the backbone to your regulatory and standards compliance. We enable you to make it Audit-Ready and Easy-to-Use.

Quality & Compliance Process Builder

All the documents, templates, and processes you need to support your compliance efforts. Seamlessly integrated into your QMS.

Grant explains how it all works

Founder & CEO of RedPeakTechGroup

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Software Validation

For Medical Devices and Automated Manufacturing & Inspection Systems

Validation Voyager

Starter

Most Popular

Compliance Co-Pilot

Standard

Regulatory Navigator

Advanced

Templates Library Access

(Validation, Protocols, Reviews)

SOPs for Software Validation

FDA QSR, ISO 13485, MDSAP Compliance Checklist

Self-paced Online Training

Email & Call Support (2 group calls)

Consultation Calls (Up to 2/wk)

Expert Document & Activity Feedback

Gap Analysis Support
(FDA QSR, ISO 13485)

ISO 14971 Risk Management Support

External MDSAP Audit Prep

Full Validation Execution (SW Requirements, Protocols, Reviews)

Custom Validation Protocols & Reports

Comprehensive Risk Management File (ISO 14971)

On-site Support

Audit Support (Internal & External)

Custom Staff Training

Price:

$999/mo

Price:

$3,950/mo

Price:

$9,950/Mo

Standards We Help You Navigate

Testimonials

FAQs

What are the key requirements for FDA software validation?

The FDA requires that software used in medical devices be validated to ensure it meets its intended use and performs reliably. This includes establishing software requirements, designing and developing software according to these requirements, and validating the software through rigorous testing. The process should also include documentation of all validation activities and results.

How do I ensure my software validation process meets FDA guidelines?

Follow FDA guidelines such as those outlined in the FDA's General Principles of Software Validation and ISO 13485 standards. Ensure thorough documentation, implement robust testing procedures, and maintain traceability from requirements through validation to support compliance.

What documentation is needed for FDA software validation?

Key documentation includes software requirements specifications, design specifications, verification and validation plans, test protocols and reports, risk management documentation, and change control records. Documentation should demonstrate that the software meets all requirements and performs as intended.

How do I handle software changes and updates in terms of FDA compliance?

Implement a structured change control process that includes evaluating the impact of changes, re-validating the software as needed, and updating documentation accordingly. Ensure that all changes are well-documented and that validation processes are repeated for significant updates.

What are the common pitfalls in software validation for medical devices?

Common pitfalls include inadequate documentation, insufficient testing, lack of traceability, and failure to address software changes properly. Ensuring a thorough and well-documented validation process is crucial to avoiding these issues.

How can I integrate software validation into the overall product development lifecycle?

Integrate software validation early in the development lifecycle and ensure it aligns with other product development activities. Use a risk-based approach to prioritize validation activities and maintain close coordination between software development and validation teams.

What are the FDA’s expectations for risk management in software validation?

The FDA expects a comprehensive risk management process that identifies and mitigates potential risks associated with software. This includes performing risk assessments, implementing risk controls, and ensuring that any residual risks are acceptable in light of the benefits provided by the device.

How do I prepare for an FDA audit of my software validation processes?

Ensure that all documentation is complete, accurate, and up-to-date. Conduct internal audits to identify and address potential issues before the FDA audit. Be prepared to demonstrate how your software validation processes comply with FDA requirements and how you manage software changes and risk.

What are the best practices for validating automated manufacturing systems?

Best practices include conducting a thorough validation plan, performing qualification activities (IQ/OQ/PQ), ensuring proper documentation of all validation activities, and maintaining ongoing monitoring and maintenance. Additionally, assess the impact of any changes to the automated systems and re-validate as necessary.