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
Regulatory Strategy
StarFish guides you through the tradeoffs between business and regulatory strategies, helping you navigate market requirements to build a robust regulatory plan. We determine the best path to market for your device, including classification and submission type.
Regulatory Gap Analysis and/or Transition Planning
StarFish stays ahead of regulatory changes from FDA, Health Canada, the EU, and UK. We help you understand new requirements’ impacts on your products and processes, supporting design and documentation to maintain or achieve compliance.
Regulatory Guidance & Training
Navigating numerous regulatory documents can be confusing. Our experts clarify expectations from regulatory bodies, ensuring your products and processes meet standards. We offer engaging training materials and regularly support conferences and university lectures.
Pre-sub Submissions
Engage with the FDA through the free pre-sub program to de-risk your project. We craft critical questions, compile necessary documentation, handle submission requests, and support meetings and feedback responses.
Clinical Submissions
Whether you need an IDE for a US trial or an ITA for a Canadian trial, we provide documentation and guidance. We have connections with BC clinical trials and can recommend ethics boards if needed.
Product Submissions
From strategy to submission, StarFish supports your entire product development process. We have experience with FDA, Health Canada, and EU notified body submissions.
QMS Design & Implementation
StarFish helps develop your QMS alongside product development. We align your corporate structure with QMS requirements (QMSR, ISO 13485, MDSAP, MDR/IVDR). We draft QMS documents or support your SMEs in developing them, and provide independent review and auditing support. We also assist in selecting, implementing, and validating electronic systems.
Mock Audit & Independent Review
Gain additional perspective with StarFish’s auditing services. We review your processes before regulatory submission, offering insights into operational excellence and compliance. We also provide independent reviews, especially useful for small teams.
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
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.
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
Explore Our Services
Our multidisciplinary teams have all the in-house capabilities to transform your medical device from concept to final product.
Medical device design and development with a commercial launch focus. See how we support clinical trials and facilitate seamless tech transfers.
Related Resources
Overview of tools for Root Cause Analysis is an important tool in medical device development and manufacturing.
Predetermined Change Control Plans (PCCPs) Draft Guidance with Implications for Medical Device Manufacturers and regulatory framework
The U.S. Food and Drug Administration (FDA) made a significant update to its regulatory approach for in vitro diagnostic products (IVDs), including laboratory developed tests (LDTs). Detailed in a FDA Laboratory Developed Tests Policy guidance document issued on June 25, 2024.
Ready to start your QA/RA journey?