Synopsis:

Creating, processing, and reviewing product documentation for submission to regulatory bodies (FDA, EMA) for registration of medical devices under different submission paths (De Novo, EUA / Emergency Use Authorization, U-EAU / Umbrella Emergency Use Authorization. 510(k) / Pre-Market Notification, PMA / Pre-Market Approval).

Tasks/Responsibilities:

• Research, verify, and approve device information in regulatory databases, such as e.g. active device registration & listings, GUDID, product classification, device class, product code, device definition, GMDN code, GMDN terms, GMDN term preferred name, GMDN title & number, device ID, device characteristics, etc.

• Provide guidance to clients for registration of FURLS accounts.

• Engage in submission of regulatory documents for PPE (Personal Protective Equipment), including surgical masks and respirators, N95 masks (US), KN95 masks (CN), FFP2/FFP3 masks, EU type IIR masks.

• Engage in submission of regulatory documents for the De Novo registration of a Cold Ablation Robot-guided Laser Osteotome device.

• Cyber Security assessment (device classification, assessment of potential threats, vulnerabilities, mitigation measures etc.) for the Cold Ablation Robot-guided Laser Osteotome as a Tier 2 device.

• Serve as PRRC (Person Responsible for Regulatory Compliance) as defined by EU MDR 2017/745.

• Advise a client (a major Swiss life science company) in regard to

  ? regulatory requirements (GxP, Cyber Security, etc.) when moving existing software applications used in a regulated environment, that are critical to product quality, into the cloud;
  ? regulatory requirements (GxP, Cyber Security, etc.) when deploying COTS applications in the cloud;
  ? regulatory requirements (GxP, Cyber Security, etc.) when developing new

  applications in-house to be deployed in the cloud;

• Consulting in regard to best practices for introducing and deploying a scaling agile methodology (in this case: SAFe) in DevSecOps and throughout the whole organization.

• Consulting in regard to creating and implementing a Cloud Governance Framework that would blend in with, and complement, existent regulatory and quality corporate policies.

CynetiX Technology Consulting GmbH is a partner-managed Swiss consulting, research and development, and technology management firm, specializing in regulated and strictly quality driven industries, such as Medical Devices, Life Sciences, Aerospace, Defense, and Energy.

Providing consulting in the areas of Quality Assurance, Regulatory Affairs, and Governance/ Risk/Compliance to domestic and international clients in regulated industries, primarily in Medical Devices, Life Sciences, and Healthcare.

Special Operations (R&D, lab systems, special purpose & custom systems).

Tasks/Responsibilities:

Providing consulting in the areas of Regulatory Affairs, Quality Assurance, and Governance/Risk/Compliance to domestic and international clients in regulated industries, primarily in Medical Devices, Life Sciences, and Healthcare.
Consult and support clients in analysis, definition, implementation, improvement, supervision and enforcement of quality and regulatory (e.g. QSR/GxP, HIPAA/HITECH, EHR) compliance, operational safety policies, data security policies, definition, review, and improvement of the process landscape, and alignment of processes to business.

Sample Consulting Assignment:

Subject Matter: Quality Assurance / Regulatory Compliance Role: Quality & RA Manager
Industry: Medical Devices
Period: 2014/08 to 2015-01

References: 2 – 3, upon request

Responsibilities:
Supported several R&D projects (in-house und OEM) as RA and QM subject matter expert: lab analytics instruments such as readers, washers, multi-mode readers with various hardware modules/ operation modes/ assay configurations for optical detection (Luminescence, Absorbance, Fluorescence, AlphaScreen/AlphaLISA, etc.)
Provided advisory consulting as RA subject matter expert in preparation of an FDA inspection

Tasks:

• Represented the QM/RA department in project steering committees and R&D teams
• Ensured product compliance with regard to 21 CFR Part 820, MDD 93/42/EEC, ISO 13485, 14971, 62304, 62366, 60601, EU Machinery Directive, and environmental regulations (ROHS/REACH)
• Creation, maintenance, review, release of control documents such as Design Specifications, Test Plans, Test Reports, Master Test Plan, Engineering Design Output, Validation Master Plan, PQ/DQ/IQ/OQ plans, etc.
• Execution and acceptance of PQs, DQs, IQs, OQs, PLV
  Planning, coordination, and execution of various remediation activities, such as:
• Re-documentation: review, correction, re-release of obsolete/incorrect project/product documentation (DHF, DHR, DMR)
• Review, correction, re-release of risk assessments: correcting form, wording, and risk assessments in PHAs, FMEAs in the areas of design, production/process, and service
• Review, correction, re-release, and management of NCRs, CAPAs, HHAs
• Management of the DHR of various devices
• Supported continuous improvement of the process landscape: assessments, gap analysis, redesign, validation.

Sample Assignment (information on other assignments available upon request):

CoriMed, Inc. – USA

2002 – 2003

Project Manager & Technology Consultant (freelance)

Medical IT / Healthcare

Consulting, planning and pre-test implementation in a large-scale data center consolidation project. Consolidation of a Windows 2000 TS / Citrix MetaFrame environment of about 80 servers of a mixed standalone / failover / cluster configuration running Windows 2000 Advanced Server + Terminal Services, Citrix MetaFrame 1.8, NFuse, SQL Server, Exchange, into four IBM x/440 machines running VMware ESX Server. In parallel, a smooth migration of the SQL Server / Exchange environment towards an Open Source solution (Linux / IMAP / PostgreSQL), and from MS Office to an OpenOffice environment has been prepared. Integration of various UNIX-based medical applications and medical workstations (Solaris, AIX, HP-UX), and designing a connector architecture to an SAP (IS-H/Med) back-end system.

Technical project management including planning, organizing, and supervising the complete 510k & GxP compliant documentation process; working closely with clinical clients on implementation, usability, and compliance issues.

Consulting and support in the systems & operating environment analysis, and in writing development and systems documentation, such as: Proof of Concept Whitepaper, Requirements Specification, Design Specification, System Engineering Specification, Integrations Testing Whitepaper, Testing Manual, Migrations Testing Whitepaper, Migration Manual, System Failure & Disaster Recovery Whitepaper, Operating Manual.

Designed upgrade & replacement roadmap, cost analysis & control (TCO calculation), and budgeting Successfully completed the migration project on time, on scope, on budget

Development of a Medical Imaging (PACS) Online Archive. Planning, design and implement- ation of a hardware & software reference platform for a leading-edge, cost efficient digital online archiving system to store medical images (PACS), based on off-the-shelf Intel x86 Hardware and Windows NT, with standard network connection to large-scale medical imaging systems (Siemens Coroscope/ Bicor/ Polytron etc.) and real-time review devices (ACOM.M/.B/.PC), clinical data sources (HIS/RIS), clinical workstations, and clinical administrative back-end systems (IS-H/Med) via DICOM/HL7-driven communication.

Tasks/Responsibilities:

• Member of the international PSG (Project Steering Group), serving the roles of project manager, quality manager, and regulatory affairs manager for system design & architecture throughout the entire SDLC according to GMP regulations.
• Coordinated development and engineering tasks between German, U.S., and Swedish locations.
• Designed the system architecture from scratch for hardware, software, and infrastructure.
• Designed the data model, and supervised DBMS setup, configuration, and performance
• Tuning of the object-oriented database.
• Worked closely with the engineering team during implementation of the prototype,
• Integration, performance, and quality tests. Handled change request management.
• Authoring of 510(k) & GMP compliant documentation, including Requirements Specification, System Analysis Specification, System Design Specification, System Engineering Specification, and System Maintenance Specification.
• Accompanied analysis and definition of use cases, and authoring of System Administration Manual and Clinical User Manual. Prepared and supervised prototype implementation and authoring of documentation as QM for FDA auditing.
• Coordinated communications between distributed developer teams in Germany, the U.S., Sweden, and India. Organized and drove information flow from DICOM task force and developer team of the PACS class library (pre-Syngo product) to the ACOM.Net developer teams.
• Worked closely with clinical users during design & implementation phase, drove and supervised installation and operation of prototypes at hospitals, taking part in clinical trial tests (St. Mary's Hospital Chicago, German Heart Disease Center Munich, Heart Disease Research Center Bad Oeynhausen).
• Close involvement with working out the product development roadmap, upgrade & replacement roadmap. Managed QM/QA on cost analysis & budgeting, throughout all phases of the project.
• Accompanied early adopter clinical clients during product introduction as aftersales technical manager, providing the clients a direct link to 3rd level technical support and engineering.