Medical Writing: Your partner in Literature Search, Scientific and Clinical Evaluation Reports

• Scientific Validity Reports (SVR), Performance Evaluation Plans and Reports (PEPs and PERs) for IVDs, in compliance with Regulation (EU) 2017/746 IVDR; Clinical Evaluation Plans & Reports (CERs) for medical devices from all risk classes, in compliance with Regulation (EU) 2017/745 MDR and MedDev 2.7.1, Rev 4
• Risk Management Plan and Report for a device from any risk class, in compliance with ISO 14971:2019
• Post-Market Surveillance (PMS): PMS Plan & Report, Periodic Safety Update Report (PSUR), Post-Market Performance Follow-up (PMPF) and Post-Market Clinical Follow-up (PMCF) Reports, Summary of Safety and Performance (SSP) and Summary of Safety and Clinical Performance (SSCP), in compliance with Regulations (EU) 2017/746 IVDR & 2017/745 MDR
• IFUs and Package Inserts

Quality Assurance: Your partner in QMS implementation and Product Quality Compliance

QMS Implementation:

• IFUs and Package Inserts
  • QMS gap assessment against ISO 13485:2016, MDSAP, EU-IVDR and EU-MDR requirements
  • QMS gap remediation: upgrade existing Quality Systems to comply with specific Regulatory requirements, e.g., requirements related to PMS, Risk Management, and EUDAMED
  • Build elements of the Quality system from scratch, including drafts of Quality Manual, Quality Policies, and SOPs, in compliance with 21 CFR Part 820, ISO 13485:2016, ISO 14971:2019, MDSAP requirements, EU-IVDR and EU-MDR, as applicable
• Implement and maintain a modular e-QMS system => digital transformation of QMS from a paper-based system
• Build or update product Design History Files (DHF), Device Master Record (DMR), Medical Device Files

Quality Engineering Support:

• Design Control Activities during Feasibility, Development, Verification/ Validation, and Design Transfer to Manufacturing
• Risk Management Activities, including Risk Assessment via dFMEA, pFMEA and User FMEA
• Process Validation
• Computer System Validation (CSV), Software Validation, Data Privacy and Cybersecurity
• Remediation in response to FDA Inspectional Observations, FDA Warning Letters/Citations (FDA 483s)

Quality Audits: your partner in QMS Gap assessment and Internal Audits

Several ISO 13485:2016 and ISO 90011 Certified Lead Auditors in our Audit team, with years of auditing experience in the medical device space

• Audit criteria include the following Standards and Regulations:
  • ISO 13485:2016
  • ISO 14971:2019
  • MDSAP
  • MDR (Technical File and QMS)
  • IVDR (Technical File and QMS)
• Preparatory audits using QSIT (Quality System inspection Technique by FDA) prior to actual FDA inspections/audits (e.g., GMP audit, PMA audit)
• Supplier, Vendor and CMO Audits
• Lab Preparatory audits against ISO 15189 designed to meet federal CLIA and state regulatory requirements, prior to Lab accreditation by COLA Inc.

Staffing Solutions:  Your partner in Talent Acquisition across multiple functions

• Spans the Medical Device, Digital Health, Diagnostics (IVD) and Biologics/Biotech industry
• Functional areas: R&D, Product Development, Quality Assurance, Quality Control, Regulatory Affairs, Project Management, Manufacturing, Validation (including Software and Computer Systems Validation), Clinical Operations / Clinical Trial Management
• Permanent (Direct Placement) and Contractual Employees (Contingent Workforce)
• ZenBiomed, Inc. differentiates itself from other Staffing companies in the market:
  • founders are SMEs in areas where Staffing Solutions are provided
    • leads to a deeper technical understanding of client requirements.
  • targeted sourcing of candidates from our extensive professional network or in-house candidate database
  • technical screening of  candidates.
  • oversight, as needed, to ensure quality of the project deliverables.
  • flexible engagement and pricing models based on client needs