Our Services
Regulatory Affairs: your partner in Regulatory strategy and submission.
- Regulatory Classification, Conformity Assessment Route, Regulatory strategy and roadmap.
- US FDA Submissions: Pre-Sub (Q-Sub), IDE, CLIA Categorization / CLIA Waiver, Breakthrough Device Designation, Traditional and Special 510(k), De Novo, PMA, and PMA Supplements.
- Technical File Gap Assessment against Regulation (EU) 2017/745 (MDR), Regulation (EU) 2017/746 (IVDR), UK Medical Device Regulations (UK MDR) 2002, No 618.
- Implementation of EU-IVDR and EU-MDR transition plan for devices from all risk classes
- Compilation of entire Technical Documentation for review by Notified Body & UK Market Conformity Assessment Body (UKMCAB) => CE Marking in the EU and UKCA Marking in Great Britain.
- Support with Post-Market Surveillance activities and EUDAMED compliance.
- Support with Regulatory Compliance: Prepare Regulatory dossiers; work directly with International Regulatory bodies, country affiliates, authorized representatives or distributors to secure establishment license, GMP certification, new registration or renewal of devices, in compliance with country-specific requirements
- Act as U.S. Agent for non-US companies .
- Post-Submission Filings (Amendments & Supplements, Change Notifications, Letter to File).
- Compliance with Clinical Lab Regulatory requirements (CLIA/CAP/NYSDOH).
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
- founders are SMEs in areas where Staffing Solutions are provided