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What We Do Advisory Services Quality & Compliance Solutions

Quality & Compliance Solutions

Consistency, traceability, and product compliance are non-negotiables in MedTech. Avania’s Product Compliance and Quality Solutions partner with you to build, validate, sustain, and audit robust quality systems, so your product journey is anchored in integrity, performance, and trust.

Key Differentiators:

  • Celebrating 20+ years of ISO 13485 certification the bar for compliance in MedTech
  • 100+ MDSAP/ISO 13485 Audits supported by our expert team
  • 400+ Product Compliance projects supported design files to cybersecurity
  • Experts in scalable QMS systems implementations for medical devices
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Facing the Challenges of

Product Compliance and Quality in MedTech

Delivering medical technologies globally means navigating evolving standards, regulatory scrutiny, and complex product lifecycles. MedTech innovators like you often wrestle with:

  • Designing a QMS that scales with growth and complexity
  • Identifying and complying with changing global product compliance regulations
  • Meeting multiple regulatory standards (e.g. FDA QSR, ISO 13485, MDR)
  • Maintaining documentation, training, traceability, and change control
  • Managing nonconformities, CAPAs, complaints, and recalls
  • Preparing for internal, supplier, and regulatory audits
  • Ensuring inspection readiness across regions

Missed details or gaps in product compliance or in quality systems can lead to costly audits, recalls, and delays to product launch and commercial distribution.

Why Avania: Your Champion in Product Compliance & Quality Services

Our Experts

Meet the Experts Behind Our Compliance Excellence

Speak with our Experts
Catriona Boyd

Director of Quality Services

Catriona Boyd, RAC, CMDA

  • 15+ years leading FDA-ready global quality systems
  • ISO 13485 and TPEC Lead Auditor
  • Dedicated expert in regulatory compliance for medical devices
  • Specialized expert in Design History File (DHF), Verification/Validation (V/V) and gap analysis
Matt Asselin

VP Product Development and Engineering

Matt Asselin, MSc

  • 20+ years leading FDA-ready global quality systems
  • ISO 13485 expert with manufacturing expertise in design-build-test of medical devices
  • Prior engineering leader at Phillips with extensive 13485 product compliance expertise
  • Specialized expert compliance engineering
Acacia Parks

VP Regulatory Compliance and Engineering

Acacia Parks, PhD, MBA, RAC

  • 20+ years of regulatory and scientific leadership experience
  • Doctorate Degree in Psychology
  • Specialized expert in Software as a Medical Device (SaMD), Digital Therapeutics (DTx), wearables 
  • Involved in more than 50+ clearances for software and algorithm/AI devices
  • Thought leader in next generation software medical devices, imaging, and neuromodulation 

Integrated MedTech and Laboratory Product Compliance and Quality Expertise

We don’t do generic compliance. Avania brings a deep understanding of the device, diagnostic, and combination-product space, integrating quality considerations into your regulatory and clinical strategy from the start. From ensuring site compliance to product compliance and clinical trials compliance, we have your GxP and QMSR needs covered.

Product Compliance from Engineering Experts

Medtech manufacturers face unique challenges in dynamic global manufacturing and compliance regulations that impact sites, products, and distribution. Our engineering experts are geared for the needs of the medical device and laboratory services industries.

Partnership, Not Just Execution

We operate as an extension of your team: communicating openly, embedding ourselves in your process, and aligning with your mission to bring safe, effective products to market.

Flexible, Tailored Engagements

Need full product compliance, QMS design, audit support, or just inspection readiness? We customize our support to your maturity, technology, and risk profile, scaling services as you grow.

Operational Rigor

We bring structured, repeatable processes built for MedTech, with product and site compliance, continuous improvement, and traceability at the core.

Core Product Compliance & Quality Capabilities

Detailed Quality Service Offerings

  • QMS design aligned with FDA QSR / ISO 13485 / MDR / TGA
  • Quality manual, policies, and procedural documentation
  • Design control, risk management, and change control
  • Supplier/vendor management, traceability, and calibration
  • Inspection, labeling, packaging, storage, and distribution controls
  • Complaint handling, returns, and field corrective actions
  • CAPA system design, root-cause analysis, and verification
  • Process validation, product release, and sterilization support
  • Training and competency programs
  • Baseline gap analysis across systems and lifecycle stages
  • Internal audits, supplier audits, and system maturity reviews
  • Audit preparation (FDA, notified body, ISO, MDR)
  • GCP, GLP, GTP auditing as needed
  • Vendor and supplier compliance audits
  • ISO 14155 and ISO 13485 Mock audits / regulatory inspection simulations
  • Training for internal teams and investigator sites
  • Advisory support for responding to audit observations
  • Development of corrective action plans aligned with regulatory expectations
  • FDA Unified Registration and Listing System (FURLS) establishment registration and annual compliance management
  • End-to-end lifecycle documentation and change control management across development, validation, and post-market phases
  • Device Registration and Listing Module (DRLM) optimization and product code classification guidance
  • Regulatory submission document preparation, version control, and compliant archival systems for FDA, EU MDR, and global requirements
  • Technical file compilation and maintenance with integrated FURLS listing coordination
  • Cross-functional document workflows and FURLS account management for owner/operator and official correspondent roles
  • Fractional quality leadership placement (interim VP Quality, Quality Directors, and RA managers)
  • Embedded FSP quality teams for ISO 13485 implementation and FDA QSR compliance projects
  • Staff augmentation for regulatory submissions, audit preparation, and remediation activities
  • Interim management during quality system transitions, M&A integrations, and organizational restructuring
  • Project-based quality team deployment for FDA 483 response, Warning Letter remediation, and CAPA closure
  • Specialized expertise placement for EU MDR transition, cybersecurity compliance, and post-market surveillance functions

Detailed Product Compliance Service Offerings

  • ISO 14971 risk management process implementation and FDA risk analysis documentation
  • IEC 62366 usability engineering and human factors validation for regulatory submissions
  • Design controls optimization and FDA 21 CFR 820.30 compliance integration with global quality systems
  • Clinical evaluation planning and clinical evidence compilation for FDA, EU MDR, and global submissions
  • Packaging and labeling compliance validation including shelf life studies and transport validation
  • Material characterization and supplier qualification programs for regulatory traceability and change control
  • IEC 60601-1 electrical safety and essential performance requirements compliance strategy
  • Electromagnetic compatibility (EMC) testing coordination and IEC 60601-1-2 regulatory documentation
  • Wireless and RF device regulatory strategy including FCC coordination and spectrum management
  • IEC 60601-1-8 alarm system design and validation for critical care applications
  • Connected device cybersecurity frameworks and wireless communication protocol validation
  • Electrical risk management integration with ISO 14971 and fault condition analysis for regulatory submissions
  • IEC 62304 medical device software lifecycle process implementation and ISO 13485 integration
  • AI/ML quality frameworks and algorithmic validation protocols for continuous learning systems
  • Software verification and validation (V&V) planning for SaMD regulatory submissions
  • Predetermined Change Control Plans (PCCP) and software change management quality systems
  • Software configuration management and traceability documentation for FDA and EU MDR compliance
  • Emerging software and AI model governance frameworks and quality assurance for machine learning development lifecycles
  • FDA intercenter coordination and assignment request strategy for CDER/CBER/CDRH jurisdiction determination
  • Combination product regulatory classification and lead center identification for drug-device, biologic-device, and device-led combinations
  • Intercenter agreement development and regulatory pathway optimization across FDA centers with conflicting requirements
  • Good Manufacturing Practice (GMP) harmonization for device and pharmaceutical components under unified quality systems
  • Clinical trial design integration addressing both safety/efficacy and device performance requirements across combination product components
  • Risk management frameworks spanning device ISO 14971 and pharmaceutical ICH guidelines with integrated benefit-risk assessments

Technology Expertise

Our regulatory expertise spans all critical medical device technology segments where specialized expertise drives competitive advantage:

  • Active Implantable Devices – Expert guidance for ICDs, pacemakers, neurostimulators, and other active implants requiring extensive post-market surveillance and cybersecurity frameworks
  • Minimally Invasive Surgery Instruments – Regulatory optimization for advanced energy devices, single-use technologies, and robotic-assisted surgical platforms
  • Software as Medical Device (SaMD) & AI/ML – Leading expertise in FDA Digital Health pathways, predetermined change control plans, and algorithmic validation for continuous learning systems
  • Wearables & Remote Patient Monitoring – Strategic guidance for consumer-to-clinical device transitions, RPM reimbursement optimization, and digital biomarker validation
  • Robotics & Surgical Systems – Comprehensive support for robotic surgery platforms, rehabilitation devices, and capital equipment regulatory strategies with extensive clinical evidence requirements
  • Interventional Devices – Deep experience across cardiovascular, neurovascular, and oncology interventional technologies, including complex Class III PMA pathways and specialist training programs
  • In Vitro Diagnostics (IVD) – Specialized in EU IVDR compliance, companion diagnostics, and complex clinical validation strategies for next-generation diagnostic platforms
  • Medical Imaging Equipment – Strategic support for advanced imaging technologies, AI-enhanced diagnostic systems, and radiation safety regulatory requirements
  • Emerging Technologies – Agile expertise across breakthrough device categories and next-generation MedTech innovations requiring novel regulatory approaches
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Therapeutic Focus

Avania’s quality and compliance capabilities span every major therapeutic area we serve.

  • Cardiovascular – Quality and compliance for complex, high-risk devices
  • Neurovascular – Proven quality systems for cerebrovascular technologies
  • Neurology – Robust controls for neurological device reliability
  • Musculoskeletal & Orthopedics – End-to-end quality for surgical and implantable devices
  • Aesthetics & Dermatology – Ensuring safety and consistency for aesthetic innovations
  • Endocrinology, Gastroenterology & Urology – Quality oversight for metabolic and urologic solutions
  • Medical Oncology & Radiology – Compliance excellence for diagnostic and imaging technologies
  • Other Expertise – Scalable quality systems for emerging MedTech fields
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Global Reach & Local Insight

Quality and compliance is not “one-size-fits-all” globally. Avania’s regional footprint ensures your QMS and audit readiness reflect local regulatory expectations, cultural practices, and inspection norms. Wherever you’re launching — U.S., EU, Asia-Pacific, or beyond — our team brings global standards with local sensibility.

Client Success & Impact:

Proof of Our Partnership

Case Study

Challenge:

A Series A MedTech startup with a MedTech founder lacked any quality management infrastructure, risking significant delays to their FDA IDE application and clinical trial timeline.

Avania’s Approach:

We rapidly implemented a risk-based ISO 13485 QMS tailored for early-stage operations, focusing on design controls and clinical readiness rather than full manufacturing systems. Our Toronto Design Lab supported human factors integration while establishing scalable quality processes that grew with the company.

Outcome:

The streamlined QMS enabled IDE submission six months ahead of original projections, with FDA accepting the quality documentation without additional requests. Clinical trials began on schedule with robust quality oversight.

For startups, right-sized quality systems accelerate rather than burden early development timelines.

Case Study

Challenge:

A medical device manufacturer’s internal quality team needed specialized AI/ML validation expertise for their SaMD submission, requiring seamless integration with existing 13485 processes without disrupting ongoing operations.

Avania’s Approach:

We embedded our engineering and product development oriented quality specialists directly within their quality organization, co-developing validation protocols and predetermined change control documentation. Our team worked alongside their quality engineers to enhance existing design controls with cybersecurity requirements while maintaining their established quality culture.

Outcome:

The collaborative approach resulted in successful MDSAP/ISO 13485 inspection, becoming a template for the company’s future pipeline.

Strategic quality partnerships amplify internal expertise rather than replacing institutional knowledge.

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our approach

Avania’s Integrated Approach to Quality & Compliance

Avania operates as an extension of your team, bringing transparency, collaboration, and shared purpose to every quality initiative. Our quality and compliance expertise integrates regulatory insight, operational excellence, and hands-on industry experience to ensure your systems are not only compliant, but built to last.

Whether you need comprehensive end-to-end quality management or focused support for audits, CAPAs, or inspection readiness, Avania adapts to your organization’s needs — strengthening your framework, scaling with your innovation, and upholding the highest standards of consistency, reliability, and global compliance across every engagement.


Your Path to

Confidence

Product compliance and quality is not an afterthought — it’s the foundation of credibility, safety, and adoption. Partner with Avania to build a compliance framework that evolves with your device and market ambitions.

Tell Us About Your Project