Michael Fischer ***** Celtic Ash Drive Ruskin Florida 33573, ad4ddp@r.postjobfree.com, 215-***-**** c

https://www.linkedin.com/in/michael-fischer-302b837/

Depth of Experience (Class 3, Class 2 (a, b) and Class 1 devices)

Over forty years of medical device works, R&D, D&D, Medical device, IVD, and pharma experience with a 21’st century focus on quality and regulatory affairs. I did engineering including design and development and more recently management of the regulatory and product quality paradigm: US medical devices, UKCA, MDD/EUMDR medical devices, software (SAMD and SIMD), and IVD/IVDR product quality and regulatory affairs. Management and leadership training and experience at project and program levels is noted.

Education

Formal Education: Masters’ degree in Biological Sciences, degree in Electrical Engineering

BSEE - Indiana Inst. of Technology, Fort Wayne, IN;

Biology - Saint Joseph’s University, Philadelphia, PA,

MA Biology – Montclair State University, Upper Montclair, New Jersey

MA Education – Arcadia University, Glenside, PA (for Training in SOPs and Regulatory requirements)

Continuing Education, Training, and Background (BSI training/certifications are listed below):

BSI audit and assessor training and certifications: ISO 13485:2016, ISO 9001:2015, ISO 14971:2019, MDSAP, MDD, IVD, IVDR, and EUMDR

Training by SQA Services: CFR 820 requirements, ISO auditing, ISO 13485: trained as an ISO auditor

Training – CE Testing and Compliance by NMI USA, a Notified and Competent Body

Training – IEC 60601 and ISO 14971 by UL at Raleigh: included Design Control and Risk management analysis with later training in ISO 13485: 2016 and ISO 10993-XX.

Training – by Johnson & Johnson segregate AMA: Interpersonal Relationships, Project Management, Competent Interviewing and Effective Public Speaking, plus Hobbs: Time Management

Training in QSR and GMP/GLP: includes developing and executing IQ, OQ, and PQ procedures and SOP’s, ISO trained and training and software development/ validation under 21 CFR part 11

Training – ROHS, REACH and RoHS-2 Testing and Compliance; by UL and INTERTEK

Training - ASQ courses and BSI courses in CAPA, including finding the true root cause

Training - Company purchased Training: Six Sigma classes; in statistical analysis, DMAIC, continuous improvement, Lean enterprise

Training - Management Training by Johnson and Johnson via various surrogate training companies.

Validations and verifications under part 4 and parts 21 CFR 801, 803, 806, and 820

Experience with: Windows 10/11, ORCAD, Microsoft Office, VISIO, PROJECT, MINITAB, SAMD, SIMD

Software: and Firmware Addendum:

This applicant has Medical Device quality and regulatory experience of software within development, verification and validation testing. I have experience with IEC 62304 and 21 CFR Part 11. I have worked in ultrasound imaging devices, various clinical blood and PCR analyzers. I have exposure to medical imaging, pattern recognition, machine learning, and system programming. I am familiar with International and National standards for the design, development and regulation of software medical devices. My mantra is not just system efficacy but includes user and patient safety.

Quality and Regulatory experience includes:

Quality and Regulatory Management, Document Control, Materials Management, QMS documents to GMP, CE mark (documentation, Technical Documents, and process controls under ISO 13485/ EUMDR and IVDR), Audit/Assessor experience, and Risk Management plus 510K / PMA applications.

Azur Medical Company, Inc. 6710 Everglades Drive, Richmond, VA 23225 3/23 – 1/24.

Regulatory Specialist, Remote

This was a startup, with Class 1 and Class 2 medical, combination, and pet products. I created a full GMP and CE compliant Quality Management system, registered the premises, completed FURLS, and worked 510Ks. I employed Risk Management to EN ISO 14971:2019 with A11:2021 requirements, worked (d, p, u) FMEAs, for the Risk Plan, Risk Report, I designed labels, label copy, IFUs and started move to QMSR.

Integra Life Sciences, Inc. 1100 Campus Road. Princeton, NJ 08540 4/22 – 12/22.

Quality/Regulatory Lead, Remote

Remediation: Gap assessment, project planning, remediation for company Class 1 and Class 2a product as updated from MDD to EUMDR. Label, IFU copy and released versions for MDR, Technical Documents released, Tracking and as needed updates to all EN ISO 14971:2019 with the A11:2021 requirements by updates to the MDHA, all FMEAs, for the Risk Management, Risk Plan, Risk Report documents in preparation for a Notified Body (BSI) application for CE under EUMDR.

Alexion/Astra Zeneca Pharmaceuticals, 121 Seaport Blvd, Boston MA. 10/21 – 4/22.

Quality 4 Lead, Remote

Remediation and worked to obtain CE under EUMDR; working Combination Products, Demo Units for sales, and an on-a-card IVD(R) test in an EUMDR, IVDR, ISO 13485:2016 +A11:2021 environment with submission to an EU Notified Body (NSAI) and supporting a BLA (Biological) application here in the USA. My gap analysis was confirmed by NSAI in stage 1 review and I also worked the labels and label copy/ and IFU development. Other works included preparing company for MDSAP due to South America and Canada sales. The company SOPs/ WI and structures were/are in change control as Vault Quality, TRACKWISE, and SAP changes were upgraded and released while doing a Stage 1 Audit in favor of the coming Stage 2 for our QMS and EUMDR allowing a control marked CE label on product and meeting the Low Voltage Directives for the demo device to allow FCC and a self-declared CE for the demo device.

BSI – Herndon, VA. 5/19 – 10/21

Trained and Certificated Internal, External and Lead Auditor and Certifications Assessor

Lead Auditor ISO 13485:2016, Lead Auditor ISO 9001:2015, Lead Auditor for MDSAP – Medical Devices Single Audit Program (all jurisdictions), and Certification in: MDD/CE, SIVD, IVDD, IVDR, EUMDR, ISO 13485:2016 as updated and ISO 14971:2019 as updated. My functional work was to visit BSI clients for certification, re-certification, remediation or surveillance audits to document/recommend certificate renewal, continuance, or withdrawal and if discovery of Major or Minor QMS findings (ISO 13485:2016 and ISO 9001:2015), closure of any such findings. I also completed Phase 1 and phase 2 assessments for IVD, MDD, MDR 2017/745, and IVDR 2017/746 certifications.

NORDSON MICROMEDICS – Eagan, MN. 2/18 - 11/18

Quality Systems / Regulatory Consultant

In response to Notified Body findings, I worked CAPA’s to closure. After a review of the company’s Regulatory and Quality stance. I made updates to the documentation system, worked labels and label copy/ and IFU development, composed risk reports, reviewed validation report, built technical files for 2 new products, and made improvements to the EU technical file of a third product. Work scope also included helping the company implement ISO 13485:2016 and meet MDSAP for Canadian sales. Additional activities included preparing for new product release and compliance to Medical Device Regulation 2017/745 for CE.

LIA Diagnostics, Inc - Philadelphia, PA. 10/16 to 4/17

Quality Systems / Regulatory Affairs Consultant

After predetermination meetings with FDA, prior to 510K submittal, I wrote a cGMP based QMS including Design Controls, Risk Management, CAPA, Complaint processing, Continuous Improvement, Statistical Methods etc. and composed Test Methods (work instructions) and production forms for records in the DHR; I completed labels and label copy/ and IFU development, started Production of a fully disposable HCG (pregnancy test) with QC testing and production controls. Final work was training personnel under the new QMS to allow product to move into the marketplace.

CONMED Corp - Utica, NY 5/16 to 10/16

Quality Systems / Regulatory Affairs Consultant

SOP updates for/to Design Controls, Risk Management, Complaint processing, Continuous Improvement, Statistical Methods and Test Method Validations; then processing updated design documents and the risk management records for an updated design including the Design Controls and the design FMEA and then moved to culling complaints (and searching the MAUDE system) for occurrence calculations and later to aid in qualifying device adverse events per the MDR specification along with filing FDA form 3500A (complaints).

Zephyr Technologies, Inc - Annapolis, MD now part of MEDTRONICS Inc 4/15 to 8/15

Quality Systems / Regulatory Affairs Consultant

I was hired to enhance quality systems, and develop regulatory strategies, including creation of documents for CE Mark application, enhance labels and label copy/ and IFU development. I did many of the 510K stand worked the clinical data. The device was a telemedicine product for the detection and monitoring of patient vital signs on an outpatient basis.

Parker Laboratories, Inc - Fairfield, NJ 10/14 to 2/15

Sr. Quality and Regulatory, Consultant

Design Controls, Risk Management, and 510(k) Applications: I was hired to implement Design Controls and Risk Management systems under their QMS, so we could implement regulatory required 510(k) application (documents) for new products and updates for products already in production (new labels and formulation changes). Prepared and submitted “Traditional” and “Special” 510(k) documents.

SYNTHES, Inc., a Johnson and Johnson Company - West Chester, PA 06/13 to 10/14

Senior Risk Management, Quality and Regulatory Engineer, Consultant

Originally hired for a limited number of remediation tasks, I had completed upgrades in this area for legacy products where my QMS, ISO - 60601, ISO - 14971:2012 and ISO - 13485:2012 experience and training were put to use. My contract was extended to do software validation, complaints auditing, assist with new 510Ks and CAPA closure to help remediate an FDA letter and bring to market both line extensions and new products.

I did labels and label copy.

MOBERG Research, Inc - Ambler, PA 01/13 to 06/13

Manager of Quality Assurance and Regulatory Affairs

A startup without a functional QMS, wanting ISO -13485 and CE, to sell EEG instruments on a global scale. The EEG instrument would also correlate other instruments' information (e.g., vital signs), for real time display in an ICU. I established a CAPA program, Complaint’s system, Training and Management Review Systems also labels and Statistical Techniques. Got FDA premises registration and I instituted a quality records system and clarified the Device History Records (DHRs) and calibration plus ESD test logs, while I visited vendors. End result: a fully functional QMS, with ISO13485 certification under way.

SYNERGETICS, Inc EAST - King of Prussia, PA 03/11 to 12/12

Manager of Quality Assurance and Regulatory Affairs

Managed the QC, QA & RA functions at this facility: Revised or completed SOP's, Kaizen, Six Sigma, a 510K, continuous improvement, Lean, risk management, applications to CSA, INTERTEK, UL, vendor SCRF (Supplier Change Request Forms), internal and external audits, training, CAPA, Complaints, Non-Conforming Product and statistics (Pareto of complaints, MRB, CAPA, repairs). I authored a 510K, CE Technical Files/submission and letters to file, and maintained the Device Master Records for products/ reagents. We passed a 7-day FDA QSIT audit- no 483. I worked Ministry (Japan) requirements and I did labels and label copy too.

INTEPROD, LLC - Eagleville, PA 09/08 to 03/11

Principal Engineer

This involved design and production of medical, dental and food safety devices as a team leader. The ultimate aim was to be our client company's contract manufacturer for the systems we designed (for them) including labels and labeling. This position included electronics design but also solving regulatory and quality issues. I worked CAPAs, Complaints, other GMP regulatory requirements, SOP's, work instructions, production travelers, the Device Master Record, ISO13485, ISO 10993, safety ISO60601-1 (UL, CE, CB scheme) and the 510K submission.

SQA Services, Inc. Rolling Hills Estates, CA 09/06 to 09/08

Quality Engineer and Auditor

Auditing for ISO 13485, GMP, ISO 14001, ISO 10993 and ISO 17025 as an internal and external auditor for/at Stryker Inc., Mahwah, NJ, I worked removal of non-conformances, CAPA issues and assisted with remediating QMS 483 issues, along with completing audit reports, visiting vendors for audit and recommending vendor solutions. Thereafter, I completed external audits for various SQA client companies.

PURICORE Inc - Malvern, PA 10/03 to 09/06

Product Engineer/ Team Lead

An international company where I helped pass a 6-day QSIT FDA audit (no 483). Effort: design and move to production sterilization fluid generation equipment. The fluids are Chlorine based, used to protect foodstuffs and also disinfect returned medical, pharmaceutical, and dental equipment. Design included Analog, Digital and Microprocessor circuitry, and I composed portions of the 510K application. Product met UL, MDD and GMP requirements. Production with sales topping $13 Million. I managed 5-contract manufacturers and helped maintain product while working on new designs and meeting Quality and Regulatory requirements.

IMMUNICON Corp - Huntington Valley, PA, 10/02 to 10/03

Principal Engineer

Joined a team and transformed an engineering prototype medical instrument for the identification of cancer cells in human blood tissue into a finished medical instrument. Final (re)design included low noise amplifiers, microprocessors, FPGAs, and optics; I wrote SOPs, travelers, and I redesigned system cables and harnesses for low EMI/RFI operations. I completed system labels and a Technical File for CE; once I completed that work, this device went into production.

MOLECULAR CIRCUITRY Inc - King of Prussia, PA, 4/00 to 5/02

Program Manager

I was group leader for production of an instrument that detects pathological bacteria in foodstuffs. I moved this instrument into QSR based production, and documented instrument test and assembly, labels and labeling, obtained UL, CE, GS, CB Scheme and other marks while administrating "Follow-up". I completed CAPA and complaint forms and filed with regulatory authorities.

SMITH'S Industries - Malvern, PA 10/99 to 4/00

Senior Electrical Engineer

A stopgap position in helicopter avionics using my design skills in electronics circuitry.

NUMAR Corp - Malvern, PA

Senior Electrical Engineer 5/98 to 10/99

At this company we produced an MRI based instrument to map oil pockets underground. I designed, built and installed a radio transmitter that relayed back to the surface the depth underground of the main mapping instrument.

INNOVASYSTEMS, Inc - Pennsauken, NJ 10/92 to 5/98

Systems Consultant Project Leader

Contracted out for design needs of various companies. First contract was with KULICKE and SOFFA, where I designed upgrades to IC bonding equipment that included analog and digital circuitry. Designs were then scaled to work for larger IC bonding efforts as INTEL parts grew in size and complexity. Later contracts designs involved electronics design for Inhalation therapy metering, Shampoo clarity and viscosity testing with time, cleaning agent cloth spot detection, and an artificial stomach system for the measurement of tablet dissolving rates. These designs were for various pharmaceutical companies. In some cases, I wrote the installation documents (IQ, OQ and PQ documents) and I helped install the devices at the client's site.

THE JADE CORPORATION - Huntingdon Valley, PA 9/91 to 9/92

Senior Engineer

Joined a team and designed analog and digital circuitry including microprocessors, amplifiers FPGAs and simple logic integrated circuits for floss threading devices, incontinence diapers, and contact lens production equipment for J&J companies. I also designed safety circuitry for an IBM IC wafer production oven that used corrosive and life endangering etchant gases to produce digital memory. I helped write IQ, OQ, and PQ documents and helped install the equipment at J&J facilities and at IBM facilities.

INNOVATIVE MEDICAL SYSTEMS, Inc - IVYLAND, PA 2/91 to 9/91

Senior Product Engineer

(Program Management with 37 "reports": Program level responsibilities included interface with partner pharmaceutical company's management, project planning, etc. This project, a high-speed clinical blood analyzer, was canceled after a review point where funding was lost.

SONIC TECHNOLOGIES, Inc - Horsham, PA. 9/89 to 2/91

Manager of Electrical Engineering

Program Management with 7 "reports", leadership and responsibility for instrument development, and first-article production: Accomplishments included design and development of a lithotripter (kidney stone crusher) used under contract to test disposables, and an FDA 510K approved ultrasound, QA, 1.2-Gigahertz ultrasound probe that was designed, tested and placed into QSR production.

JOHNSON and JOHNSON, IOLAB/SITE MICROSURGICAL - Horsham, PA 2/86 to 8/89

Senior Engineer, Group Lead

Production of a Class 2 eye surgical instrument for cataract removal and lens replacement {Class3}; this with a full QSR system; I wrote work instructions, SOPs, handled IFU, labels and packaging issues, and saw to compliance of the Technical File for both UL and CE. This company passed a 5-day FDA audit (no 483).

ELECTRO-NUCLEONICS Inc - Fairfield, NJ 1/82 to 2/86

Senior Electrical Engineer Manager/Team Lead

Product line was clinical blood analyzers; A new linear clinical chemistry Instrument was completed and taken to FDA/QSR production; this included a complete line of liquid reagents. My work included system, program, and project responsibilities and the implementation of documentation and controls at first production run. This program brought to production an automated analyzer that yielded $350,000,000+ in sales. I program managed a redesign group to obtain a 30% reduction in production cost. Company passed a 7-day FDA audit, I obtained UL544, and completed 3 Follow-up Audits here.

TECHNICARE, SPECIAL RESEACH GROUP, a J & J Co.)-Somerset, NJ 2/79 to 1/82

Design Engineer

Product lead for system safety. We designed and developed a diagnostic, ultrasound, imaging device for detection of breast cancer. I did analog (amplifier, filter, A/D), digital (LSTTL) circuits and some 8031-assembly software. Prior to full production, I also obtaining UL listing for the instrument, and did the electronics design of a processor based, high-definition cross-section image player for post examination physician review, and a 16-step gray scale (analog & digital) onscreen generator for real time system performance evaluation. At this company I received GMP training. My UL listing experience from my previous position was used to obtain UL LISTING of the medical device; also, we passed a 5-1/2-day FDA audit.

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