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Quality Systems and Compliance- Ensure Excellence and Trust

Master the complexities of quality and compliance to deliver safe, effective, and reliable medical devices.

Explore our Quality Systems and Compliance Pillar, your foundation for ensuring regulatory excellence and product reliability. We provide the expertise and strategies to navigate the intricate landscape of medical device compliance. Head down the page to see how we help you achieve and maintain the highest standards of quality and trust.

Quality Systems and Compliance Pillar Core Services


Expert guidance to develop and implement robust quality management strategies. 

Strong leadership and strategic planning are essential for effective quality management. Our services focus on:

  • Quality Vision: Defining a clear and actionable quality vision that aligns with your business goals.
  • Strategic Planning: Crafting long-term quality strategies to enhance product quality and compliance.
  • Leadership Training: Developing leadership skills within your team to foster a culture of quality.
  • Policy Development: Creating comprehensive quality policies and procedures.
  • Continuous Improvement: Implementing continuous improvement methodologies to enhance quality systems.

With our leadership and strategy services, you can build a strong foundation for sustained quality excellence.


Comprehensive development and management of quality management systems to ensure regulatory compliance and operational excellence.

Quality management systems (QMS) are the backbone of a compliant and efficient medical device organization. Our expertise in QMS development and management ensures your processes meet the highest standards. We focus on:

  • Quality Process Development: Designing and implementing robust quality processes tailored to your specific needs, ensuring consistent product quality and compliance.
  • Internal Audits: Conducting thorough internal audits to assess the effectiveness of your QMS and identify areas for improvement.
  • QMS Management: Ongoing management and optimization of your QMS to adapt to evolving regulatory requirements and business needs.
  • Certification Support: Providing support for achieving and maintaining certifications such as ISO 13485, MDSAP, and EU MDR, ensuring your organization meets international quality standards.
  • Document and Record Control: Establishing efficient systems for document and record control to ensure accurate, accessible, and secure documentation.

With our quality management systems services, you can achieve and maintain the highest standards of quality and regulatory compliance, enhancing your organization’s credibility and operational efficiency.


Comprehensive preparation for internal and external audits to ensure compliance and readiness.

Audit preparation is crucial for demonstrating compliance and identifying areas for improvement. Our services include:

  • Audit Planning: Developing detailed audit plans and schedules.
  • Documentation Review: Reviewing and organizing all necessary documentation.
  • Gap Analysis: Conducting thorough analyses to identify compliance gaps.
  • Audit Training: Training your team on audit procedures and best practices.
  • Mock Audits: Performing mock audits to simulate real audit conditions and identify potential issues.

Our audit preparation services ensure you are fully prepared for both internal and external audits.


Simulated FDA inspections to assess readiness and identify areas for improvement.

Mock FDA inspections help you prepare for real inspections by identifying potential issues and areas for improvement. Our services include:

  • Inspection Simulation: Conducting thorough mock inspections to mimic real FDA inspections.
  • Findings Report: Providing detailed reports of findings and recommendations.
  • Corrective Actions: Assisting in the development and implementation of corrective actions.
  • Staff Training: Training your team on inspection procedures and expectations.
  • Continuous Improvement: Implementing continuous improvement practices to address identified issues.

With our mock FDA inspections, you can confidently face real inspections with a clear plan in place.


Detailed preparation for regulatory audits to ensure compliance and successful outcomes.

Regulatory audit preparation is vital for demonstrating compliance and achieving successful audit outcomes. Our services focus on:

  • Audit Strategy: Developing comprehensive strategies tailored to specific regulatory audits.
  • Documentation Organization: Ensuring all required documentation is accurate and readily available.
  • Process Review: Reviewing and refining processes to meet regulatory standards.
  • Gap Closure: Identifying and addressing compliance gaps.
  • Post-Audit Support: Providing support for post-audit follow-up and corrective actions.

Our regulatory audit preparation services help you achieve compliance and pass audits with confidence.


Training and education programs to ensure your team understands and adheres to compliance requirements.

Ongoing training and education are essential for maintaining compliance and fostering a culture of quality. Our services include:

  • Custom Training Programs: Developing tailored training programs to meet your specific needs.
  • Regulatory Updates: Providing updates on the latest regulatory requirements and standards.
  • Interactive Workshops: Conducting interactive workshops to engage and educate your team.
  • Online Training Modules: Offering flexible online training modules for convenient access.
  • Compliance Culture: Fostering a culture of compliance through continuous education and awareness.

Our training and education services ensure your team is well-informed and compliant with industry standards.

Solutions for Every Milestone of Your Journey

Commercializing a medical product is a complex and multifaceted endeavor. At Fission, we’ve developed six Market Access Pillars to support every step of your MedTech venture from concept, to your first sales, and beyond. 

If you only need a website designed, quality procedures developed, or a full 510(k) submission, we’ve got you covered.


Market Access Pillars

Design & Development
  • Project Management
  • Usability Engineering
  • Design History File Creation
  • Verification & Validation
  • Risk Management Planning 
Clinical Development
  • Clinical Protocol Development
  • GCP Compliance
  • Clinical Evaluation Reports
  • Data Integrity & Management
  • Post-Market Clinical Studies
Quality Systems & Compliance
  • Quality Management Strategy
  • Quality Management Systems
  • Mock FDA Inspections
  • Regulatory Audit Prep
  • Compliance Training 
Regulatory Affairs
  • Regulatory Strategy
  • FDA Submissions Support
  • Regulatory Gap Analysis
  • Global Submission & Registration
  • Regulatory Compliance 
  • Brand Development
  • Strategic Marketing Planning
  • Content Strategy & Creation
  • Digital Marketing
  • Social Media Management
  • Post-Market Surveillance
  • Continuous Quality Improvement
  • Product Lifecycle Management
  • Regulatory Reporting
  • Complaint Management 

At Fission Consulting, we’re not just another consultancy—we’re your dedicated partners in navigating the complexities of the medical device industry. With a team of expert consultants spanning all core service areas, we offer unparalleled expertise and guidance at every stage of your journey, from concept to market dominance.

Contact Us Today to Learn More