Global RA/QA Consulting for Medical Device & IVD Manufacturers

QA/RA Outsourcing

In a perfect world, your regulatory compliance workload would remain steady and your best QA/RA staff members would stay with your company for the long haul. As you know, that’s not the world we live in. Experienced medical device regulatory professionals are in high demand and ever-evolving requirements are pushing QA/RA departments to the limit. NAMSA’s experienced consulting team offers a flexible option to even out your workload or address a critical project so you stay on schedule and in compliance. Here are three ways NAMSA can assist:

1. QA/RA Staff Augmentation
2. Special QA/RA Projects
3. Functional Area Outsourcing

Regulatory Consulting for Borderline and Combination Devices

NAMSA has regulatory consultants with extensive experience with medical devices incorporating medicinal substances. Our team includes experts who have previously served as Notified Body reviewers of high-risk medical devices including device/drug combinations. Our expertise covers key product areas for these products such as wound care, cardiovascular, orthopedics, and organ transfusion.

Systematic Literature Search and Reviews (FDA & MDR)

Conducting systematic clinical literature reviews can strengthen a manufacturer’s product portfolio. A thorough search and robust synthesis of available literature relevant to a particular medical device may provide important information to guide further product development, reveal much-needed evidence to substantiate current clinical indications, identify potential ‘off-label’ applications, or flag critical adverse event (AE) data.

Depending on the scope, such a review might also consider information gathered from pre-clinical studies for regulatory purposes or to provide information of commercial interest concerning a competitor device. Within the U.S., in particular, both FDA guidance and the Code of Federal Regulations stipulate the need for literature reviews as sources of information regarding safety, efficacy, and ‘known use.’

Our medical writers come from diverse clinical, technical, and scientific backgrounds to provide you with the objective answers you need to support your desired commercialization and business outcomes.

Quality Management System Implementation and Support

NAMSA has a team of quality management consultants exclusively focused on helping medical device and IVD manufacturers comply with ISO 13485, US FDA Quality Management System Regulation (21 CFR Part 820), and other international quality regulations. While ISO 13485 is considered the bedrock standard for QMS compliance, the United States, Canada, Brazil, Japan, and other markets have specific additional requirements. Our team will help you navigate those requirements or build a QMS that accounts for them in the future.

ISO 13485 and FDA Mock Audits

NAMSA’s auditing team can conduct FDA mock audits or ISO 13485 pre-certification or supplier audits. Our team will do a thorough and realistic evaluation of your quality management system (QMS) to ensure compliance with ISO 13485 standard and FDA 21 CFR Part 820 and other applicable regulations. Our team of seasoned auditors, with extensive industry experience, conducts comprehensive mock audits that simulate real regulatory inspections. We meticulously review your documentation, processes, and systems to identify non-conformities, potential risks, and areas for improvement. This proactive approach helps you address compliance gaps before actual regulatory audits, minimizing the risk of costly delays or penalties.

Whether you are preparing for an initial certification, a routine surveillance audit, or a re-certification, our mock audits offer valuable insights and actionable recommendations to enhance your QMS and ensure regulatory readiness. Partner with us to achieve and maintain the highest standards of quality and compliance in the medical device industry.

Medical Device Single Audit Program (MDSAP) Compliance

Our MDSAP compliance service offers a streamlined approach to achieving and maintaining compliance across multiple regulatory jurisdictions. By participating in the MDSAP, your medical device company can undergo a single audit that satisfies the requirements of multiple regulatory authorities, including the US FDA, Health Canada, Australian TGA, Brazil ANVISA, and Japan MHLW/PMDA. Our experienced auditors conduct thorough assessments of your quality management system (QMS), identifying compliance gaps and providing actionable recommendations to enhance your processes.

We assist in preparing for the MDSAP audit by reviewing your documentation, training your staff, and conducting mock audits to ensure readiness. This comprehensive service not only simplifies the audit process but also reduces the burden of multiple audits, saving you time and resources. Partner with us to achieve seamless MDSAP compliance and ensure your products meet the highest standards of quality and safety globally.

ISO 14971 Risk Management Consulting

NAMSA offers consulting to medical device manufacturers to implement and maintain a robust risk management system. ISO 14971 is the international standard for risk management in the medical device industry, ensuring that hazards and hazardous situations are identified, associated risks are estimated, evaluated, controlled, and that the control measures are monitored for effectiveness throughout the entire lifetime of the device. Our team of seasoned consultants offer comprehensive support:

• Risk assessment, including risk analysis and evaluation
• Risk management, including risk control and evaluation of residual risk
• Development of documentation (process, procedures, plans, reports)

We help you integrate risk management process into your quality management system (QMS), ensuring compliance with regulatory requirements and enhancing product safety. Through detailed documentation reviews, process evaluations, and staff training, we identify gaps and provide actionable recommendations to mitigate risks effectively.

Regulatory Remediation Consulting

Recovering from an FDA Warning Letter, FDA 483 or serious findings from an EU Notified Body can be daunting. You need to respond quickly, seriously, and thoroughly. Our team of regulatory experts is here to help. We will quickly conduct an analysis of the cited issues, develop a comprehensive remediation plan, and assist in drafting detailed responses to regulatory authorities.

Our services include root cause analysis, corrective and preventive action (CAPA) development, and implementation support to address compliance gaps effectively. We also offer training and guidance to ensure your team understands regulatory expectations and maintains compliance moving forward.

Clinical and Regulatory Strategy

NAMSA helps medical device manufacturers develop a comprehensive plan to navigate the complex landscape of clinical and regulatory requirements that lead to market approval.

Our team of experts conducts a thorough analysis of your device, identifying optimal preclinical, clinical, and regulatory pathways. We assist in designing and implementing required preclinical testing, clinical trials, preparing regulatory submissions, and ensuring compliance with global standards. From initial concept through post-market activities, we provide continuous support to address challenges and optimize your strategy. Partner with us to streamline your clinical and regulatory processes, reduce risks, and achieve successful product approvals.

Animal Tissue Consulting

NAMSA has medical device regulatory consultants with extensive experience in devices that utilize tissue of animal origin including experts who have previously served as Notified Body reviewers of high-risk medical devices including those containing animal tissue. NAMSA can provide a comprehensive range of services in this area including:

• Strategic advice on the use of animal materials
• Gap assessments and preparation of technical documentation in compliance with the requirements of the MDR, Regulation 722/2012 and ISO 22442
• Literature reviews and risk assessments to support TSE viral and inactivation
• Viral inactivation studies in accordance with ISO 22442-3 and regulatory expectations
• Pre- and post-market assessment of data on current zoonoses and zoonotic risk associated with the animal material
• Review and input on quality system processes for traceability, supplier controls and training
• Review of animal tissue supplier documentation
• Animal tissue specific audits
• Clinical strategy and preparation of documented justifications for the use of the animal material
• Notified Body Audit support
• Training on the requirements of ISO 22442 and Regulation 722/2012
• Preclinical and clinical testing strategies and study design
• US FDA presubmission meeting and interaction support
• Preclinical and clinical testing strategies and study design
• US FDA presubmission meeting and interaction support

AI, ML and Software as a Medical Device (SaMD) Regulatory Support

Our AI, ML and Software as a Medical Device (SaMD) Regulatory Support, provides specialized expertise to navigate the complex regulatory landscape for software-driven medical devices. With extensive experience in FDA and EU regulations, our team offers comprehensive support to ensure your software, including artificial intelligence (AI) and machine learning (ML) components, meets stringent regulatory requirements. Our expert team supports you through:

• Regulatory Strategy
• Regulatory Submission
• IFU & Labeling
• Design Control SOPs
• Software Development Procedure Development Support
• Good Machine Learning development support (for AI/ML) incorporation into design control and QMS
• Cybersecurity
• Radio Frequency (RF) Labeling Requirements Support
• Credibility Assessment
• Human Factors
• SaMD Design Controls Training
• Software Verification and Validation Testing and SBOM (Software Bill of Materials)