Design History File (DHF) Services

Design History File (DHF) Services

DHF New Product Introduction (NPI)

Challenges

  • Separating the end goal from the product
    As an Innovator, the Company made various iterations to the product. Such changes were done without a defined structure in alignment with the end goal of obtaining regulatory approval.
  • No idea is good enough until it sees the day of light
    The Company’s product was an innovative one, but due to lack of understanding of regulatory requirements, the Company did not know seeking an approval would be an uphill battle.
  • Clinically irrelevant parameters
    While the medical need was well founded, the product’s target parameters were not in tandem with the clinically acceptable parameters expected by the Physicians in the current medical practice.
  • Missing primary owner
    The company had an Engineering Team, but no single owner to take the accountability of the DHF contents; resulting in version overlap, oversight of document control, missing information, etc.
  • Increased cost
    Attributing to all the above factors, Company was undergoing employee attrition, low motivation to update and maintain DHF, redundant and/orvirrelevant testing where resources were poured in.

Solutions & Results

The solution to the Company’s challenges were offered by Elexes and comprised  of 6 primary elements P3C3 

  • Product 
  • Price  
  • Project management  
  • Complete compliance
  • Competence  
  • Continued compliance
  • Through the competence of personnel trained on DHF creation, meticulous project management and facilitated cross functional reviews and approval, all deliverables were accurately completed on time to the Company’s satisfaction
  • An effective design control procedure was implemented with systematic design reviews at the right stages, so the Company could move ahead with the end goal in sight
  • Elexes conducted data extraction and analysis to help define product’s indications for use and parameters which are clinically relevant
  • Test labs were identified taking into account ISO 17025, evaluated and added to the Approved Supplier List (ASL)

The resulting DHF was in compliance with ISO 13485, ISO 14971, IEC 62304, IEC 60601, and other applicable product specific standards and was reviewed and accepted by the regulatory and notified bodies.

DHF Sustenance

Challenges

  • Traceability
    The Company (Client) had been in the market for over 10 years, the DHFs of products updated over several years were not fully modified and there was no perfect traceability.
  • Complex regulatory requirements
    New regulatory requirements of the MDR and the manner in which the additional requirements impact the existing procedures and products technical documentation were not well understood.
  • Poor or lack of effective implementation
    Even though the procedures (SOPs) were updated as per the new requirements, the implementation was ineffectively done, mainly because of lack of dedicated personnel for such efforts.
  • Data collection and analysis
    The process of data collection from sources like an internal audit, product servicing or customer complaint was ineffectively tied with the internal quality systems to drive improvements.
  • Loss of revenue
    Inspection/audit findings resulted in products jeopardised by a recall/field action/sales cessation. Absence of a team motivated for the maintenance of legacy products via DHF remediation

Solutions & Results

The solution to the Company’s challenges were offered by Elexes and comprised of 6 primary elements P3C3

  • Product
  • Price
  • Project management
  • Complete compliance
  • Competence
  • Continued compliance
  • Leveraged the competence with various product types, quality systems, regulatory submissions, and clinical to bring together the information needed to remediate a DHF
  • A reasonably priced solution geared towards complete and continued compliance was delivered
  • Effective implementation of change control procedure was facilitated by providing additional personnel
  • The personnel also reviewed and revisited the legacy documents to ensure traceability
  • Elexes took the ownership of the entire DHF remediation, and updated clinical evaluation report, specifications, risk assessment documents, Software Requirement Specifications (SRS), Software Design Specifications (SDS), and other technical documents which were impacted by the new requirements.

The remediated DHF was in compliance with ISO 13485, ISO 14971, MDR and other applicable product specific standards and was reviewed and accepted by the regulatory and notified bodies during the regular inspection/audit.

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