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Healthcare IT Consulting

Regulatory Consultation and V&V services

Once your device is classified, the content and format of the correct regulatory submission must assure that your device is safe and effective. Once your device receives clearance, your company must implement a Quality Management System (QMS) that imposes the applicable domestic and international regulatory requirements. Key to this implementation is a risk-based interpretation that imposes requirements at an appropriate level depending on your company and its products. Your QMS must not only be compliant, but also cost-efficient; one without the other will significantly affect your ability for continued operation.

Silicus' consulting team has more than 30 years of experience across the entire spectrum of regulatory compliance. We can classify your devices, and with our close working relationship with FDA, assure correct device classification and submission content. Utilizing our experience at companies of all sizes from start-up to >$100M in sales in coordination with our Lean Black Belt certification, we can assure your customized QMS assures compliance with a lean mindset, and establishes meaningful and achievable Quality Objectives. After implementation, we won’t just walk away – we will make sure your QMS works for you as implemented.

Silicus’ consulting team also offers guidance regarding the upcoming changes to the international regulatory landscape: the imminent transition from ISO 13485:2003 to ISO 13485:2016 (deadline Feb 28, 2019), the upcoming MDSAP audit program (deadline Jan 1, 2019 (Canada)), and the eventual European Medical Device Regulations (deadline May 26, 2020).

Medical Devices Verification & Validation (V&V) Expertise

FDA Clearance

FDA Clearance

  • Device classification
  • Predicate device identification & determination of substantial equivalence
  • Preparation and submission of 510(k) document to FDA
  • Preparation and submission of follow-up response to FDA, if any
  • Establishment of change control notification program
  • Facility Registration and Device Listing
CE Mark Approval

CE Mark Approval

  • Identify the EU requirements for your product
  • Device classification
  • Determination of conformity route
  • Preparation of Technical File
  • Coordination and selection of Notified Body
  • strategic and tactical oversight/assistance in all steps of the CE marking process
Verification & Validation

Verification & Validation

  • V&V planning
  • Feasibility analysis
  • Software risk analysis
  • Compliance with certification standards
  • Software design test
  • Equipment qualification (DQ, IQ, OQ, PQ)
  • SharePoint-based tools for verification and
  • validation documentation
  • Validation of ground truth measurements
  • Validation with software phantoms
QMS

QMS

  • Risk-based assessment of QMS
  • Review of FMEA documentation
  • CAPA, including Root Cause Investigation
  • Supplier Management, focusing on outsourced processes
  • Complaint Management Process, including CAPA implications
  • QMS Upgrades
Remediation

Remediation

  • Response to FDA 483 Inspectional Observations
  • Response to Warning Letter
  • Confirmation of Warning Letter resolution
  • Response to ISO audit findings
Quality Metrics

Quality Metrics

  • Measurement of key data from current processes
  • Reject rate by product/process
  • Establishment of supplier metrics
  • Document management process
  • Field reporting metrics
Quality Auditing

Quality Auditing

  • Internal auditing
  • Mock FDA inspection
  • ISO 13485 transition gap analysis
  • Supplier auditing
  • Collaborative development of corrective actions
In-house Training

In-house Training

  • CAPA
  • Supplier Management
  • Process Validation
  • Complaint Handling and Adverse Event Reporting
  • Other programs as requested
Documentation

Documentation

  • Comprehensive documentation
  • Verification checklists
  • Validation protocols and tests
  • Develop Design History File (DHF)