NSF PROSYSTEM Medical Device Consulting and Compliance Services

Audits and Inspection Services

• NSF provides independent internal audits conducted in strict accordance with $ISO\,19011$ guidelines for quality management systems.
• Pre-audits are offered as a training and preparation tool for upcoming formal audits and inspections, including:
  • $ISO$ audits.
  • FDA inspections.
  • $MDSAP$ audits.
  • Supplier audits.
• Assessments and maintenance of quality management systems are performed by certified lead auditors with credentials from $IRCA$ and $RAB-QSA$.
• Remote audits are available for content and processes that do not require physical presence but can be reviewed in reasonable technical depth. This includes:
  • Operational activities.
  • Medical devices and services.
  • Associated risks.
• Remote audit logistics:
  • Supported by auditors, consultants, and technical experts who assist in implementation and follow-up for audits by notified bodies or competent authorities.
  • Participants can join via PC, tablet, or smartphone.
  • Requirements: An internet connection and a standard internet browser.
  • No special software is required for participants.

Trustee Services (OEM/PLM Relationship)

• Transition from pre-$MDR/IVDR$ to current regulations:
  • Previously, medical devices could be marketed as a Private Label Manufacturer ($PLM$) without disclosing the Original Equipment Manufacturer ($OEM$) and without access to the technical file.
  • Under current $MDR/IVDR$ regulations, this is no longer permitted.
  • The $PLM$ must now maintain control over the full technical documentation of the medical device.
• NSF Trustee Service facilitates the controlled exchange of technical documentation between the $OEM$ and $PLM$.
• The service is designed to ensure compliance without disclosing critical intellectual property to the $PLM$.

Corporate Profile and Standardization

• NSF (NSF PROSYSTEM GmbH) provides global leadership in consulting and professional services for the medical device sector.
• Service categories include consulting, complex project management, and interim management.
• NSF is an active member in various international standardization groups, including:
  • $ISO\,13485$
  • $ISO\,14971$
  • $IEC\,62366$
  • $IEC\,60601$
  • $IEC\,62304$
  • $IEC\,82304-1$
• Participation in co-creating standards allows NSF to strengthen a company's competitive position and identify new opportunities in biomedical engineering.

TechFile Factory: Technical Documentation Solutions

• Detailed requirements for technical documentation are found in $Annexes\,II$ and $III$ of $MDR\,2017/745$ and $IVDR\,2017/746$.
• Regulation compliance requires upgrading "old" technical files to meet current standards, including $Annex\,I$ (General Safety and Performance Requirements).
• The TechFile Factory service process involves:
  • Separating existing technical files into several components.
  • Reviewing, improving, and rewriting content.
  • Restructuring and editorially assembling files into a compliant format for $MDR/IVDR$.

Clinical Services and Investigations

• Clinical Evaluation:
  • Expertise in creating or updating Clinical Evaluation Reports ($CERs$).
  • Accelerated market access and competitive advantages through expert advice and training seminars.
• Clinical Studies:
  • Support for various types of studies and investigations.
  • Compliance with European market regulatory requirements as defined by $ISO\,14155$ and Medical Device Regulation (EU) $2017/745$.
  • Deep-dive training for all aspects of clinical study planning.

Process Validation and Analysis

• Validation of processes is conducted according to national and international requirements, such as $ISO\,13485$, $21\,CFR\,820\,QSR$, or $GAMP\,5$.
• Process analysis methods utilized include:
  • Process-$FMEA$ (Failure Mode and Effects Analysis).
  • $FMECA$ (Failure Mode, Effects, and Criticality Analysis).
  • Data analysis.
• Software Validation:
  • Retro-prospective validation of PC-software used in production, development, or quality management systems.

Surveys, Assessments, and Trend Consulting

• Post-market analysis of devices through:
  • Post-market surveillance ($PMS$).
  • Customer inquiries and competitor surveillance.
  • Analysis of complaints.
• Risk and Reporting:
  • Evaluation of technical solutions via risk assessment and clinical evaluation.
  • Definition of product-specific reporting criteria.
  • Implementation of corrections, corrective actions, or preventive actions ($C/CA/PA$).
• Trend Consulting topics:
  • Changing requirements for medical devices.
  • State-of-the-art developments.
  • Emerging market trends.
  • Harmonized standards required for compliance.

Software Life Cycle and Usability

• Usability:
  • Implementation of $IEC\,62366-1$ requirements.
  • Usability processes must begin at the feasibility phase rather than the final development stage.
• Software Development:
  • Software life cycle processes according to $IEC\,62304$ and $IEC\,82304-1$.
  • Compilation of technical documentation, including software risk management and usability files.
• Software Testing:
  • Validation of software as a medical device or process software.
  • Conducted on-site or in specialized test labs according to state-of-the-art requirements.

Post-Market Surveillance (PMS)

• Required by Medical Device Regulation (EU) $2017/745$ to ensure safety and performance.
• Manufacturers must establish processes for proactive data collection and review of clinical data.
• Collaboration with other economic operators is necessary to keep information up to date.
• NSF provides experience in analyzing the benefit-risk ratio and documenting findings in corresponding reports.

Risk and Crisis Management

• Risk Management:
  • Implementation of $ISO\,14971$ into individual risk management processes.
  • Differentiation between $FMEA$ and $FMECA$ according to $IEC\,60812$ vs. risk assessment/control according to $ISO\,14971$.
• Crisis Management:
  • Support for operational recovery under entrepreneurial or exceptional circumstances.
  • Specialized expertise in:
    • Complaints and vigilance reporting.
    • Field corrections, removals, and recalls.
    • Audit findings and $483s$.
    • Medical device tracking and reporting.
• Interim Management:
  • Provision of experienced managers, consultants, and engineers for immediate, short-term solutions on a temporary basis.

Hamburg Academy and Educational Seminars

• The Hamburg Academy serves as an interdisciplinary platform for dialog between stakeholders in the healthcare sector.
• Seminars are developed in close relationship with the notified body $MEDCERT$.
• Courses are offered in German and English, covering topics such as:
  • Risk and Quality management.
  • Clinical evaluation.
  • Medical device regulation ($MDR$).
  • Usability and medical device software.
  • Technical documentation.
• Flexible learning options include online on-demand, live instruction, and on-site workshops tailored to individual company needs.
• Symposia and Congresses: NSF plans and conducts congresses for industry, science, research, and authorities.

Regulatory Affairs and Quality Management Implementation

• Regulatory Affairs Strategy:
  • Support for submission strategies including $510(k)$, $PMA$, and $IDE$.
  • Guidance on conformity assessment and safety/performance requirements for $CE-marking$.
  • Consultation on country-specific particularities and software certification as a stand-alone device.
• Quality Management (QM):
  • Implementation of requirements from $ISO\,9001$, $ISO\,13485$, $21\,CFR\,820\,QSR$, and $QMSR$.
  • Transfer of procedures into Standard Operating Procedures ($SOPs$), templates, and checklists.
  • Coaching and motivation of employees to achieve successful organization-wide certification.