![Two members of the QA and RA team in discussion](https://starfishmedical.com/wp-content/uploads/QA-RA-Victoria-2-1108x688.jpg)
Quality Assurance and Regulatory Affairs Consulting
Mitigate risks and accelerate your time to market
Complex regulatory path? We know the way.
Navigating the journey from product design to regulatory clearance is no small feat. The path is riddled with obstacles that can delay your time to market and increase risks. To confidently steer through these complexities, you need a partner with deep expertise and a proven track record.
For over 25 years, our team has been the trusted ally for medical device and diagnostics companies, providing unparalleled quality assurance (QA) and regulatory affairs (RA) support. We work seamlessly with your product development and manufacturing teams to ensure compliance and keep your projects moving forward. Our strategic approach not only mitigates risks but also accelerates your time to market, giving you a competitive edge.
An Integrated Approach to Quality and Regulatory
Our quality and regulatory experts are always ahead of the curve, keeping up with ever-changing regulations so you don’t have to. Our ISO 13485 certified and FDA registered manufacturing facility guarantees that your project operates under a robust and compliant quality management system (QMS). Whether you require comprehensive QA/RA guidance or specialized expertise, our consultants craft tailored strategies that align with your goals, timeline, and budget.
Our Capabilities
Chart Your Course with Expert Regulatory Affairs Consulting
Navigating the approval process for medical devices can be complex, with multiple paths to choose from. Our QA/RA consultants are here to guide you, identifying the route that best aligns with your business strategy. Leveraging extensive knowledge of the latest regulatory requirements and years of communication with regulators, we ensure your decisions are well-informed and strategically sound.
Expertise to Navigate Global Regulatory Landscapes
- Extensive experience with the FDA, EU notified bodies, Health Canada, and other regulatory authorities worldwide
- In-depth regulatory research to understand and apply relevant requirements
- Strategic regulatory planning tailored to your business needs
- ISO 13485 implementation consulting for robust quality management systems
- Accurate classification and predicate identification
- Expert regulatory input integrated into design requirements
- Continuous monitoring to identify and address regulatory changes impacting your projects
- Comprehensive regulator communications and support, including FDA Q-Submission and Pre-Submission programs
- Preparation and submission of complete regulatory packages
Stay the Course with Quality Assurance and QMS Support
QA is embedded in all we do. Our team remains fully engaged in your project, so you can be confident that you’ll arrive with a safe, effective, and compliant product.
Our experience includes:
- QMS design, implementation, and maintenance
- Verification and validation support
- IEC 60601 safety certification support
- Writing project-specific quality documentation
- Requirements generation and risk management support
- Ensuring traceability throughout DHF documentation
- Reviewing documentation to ensure regulatory success
- Providing guidance and solutions to quality challenges
- ECR/NCR process compliance and impact assessment
- Quality controls on prototypes and product builds to ensure safe and effective product release
- Biocompatibility assessments, sterilization efficacy and validation studies, and other third-party testing
What Our Clients Have to Say
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Ian Maclean
Project ManagerKoven Technology CanadaI commend you for your vision in looking well ahead to regulatory and contract assembly issues, as well as a decision to concurrently develop key prototypes. This ultimately led to a successful design concept. All initial design requirements were satisfied.
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Michael Baker
CEOOtoharmonics Corporation“I am extremely happy with StarFish support while setting up a QMS for Otoharmonics and the Levo System tinnitus sound therapy device. I’ve worked with a lot of QMS people in my life and the StarFish team are the most helpful and easy to work with.”
QA/RA Across the Product Lifecycle
Impact of New FDA Laboratory Developed Tests Policy
![FDA Laboratory Developed Tests Policy](https://starfishmedical.com/wp-content/uploads/StarFish-Medical-Toronto_1-660x690.jpeg)
Explore Our Services
Related Resources
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In this episode of Bio Break, Nick Allan and Joris van der Heijden tackle the fascinating challenge of targeted drug delivery. When administering drugs to specific areas in the body, how can we be certain they reach the intended target? Nick shares an exciting example involving an intranasal device designed to deliver drugs precisely to the olfactory cleft—an area located between the eyes.
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Medical Device Commercialization Resolutions include Improved communications, aligning goals, using new tools, going paperless
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Nick Allan and Joris van der Heijden dive into a critical concept in drug delivery and biopharmaceutical development: shear stress. Understanding shear stress, especially when dealing with delicate therapies like cell and gene treatments or mRNA vaccines, can have profound effects on drug viability and efficacy. Nick walks us through how shear stress is identified, measured, and mitigated during product design and development.
Ready to start your QA/RA journey?