F. David Rothkopf Email & Phone Number

Ashland, Ma, Us

Boston, Ma, Us

Perform Quality System audits and assessments for compliance to FDA regulations, MDSAP, JPAL, ISO, and Canadian standards• Act as FDA liaison during FDA inspections• Participated in over 400 compliance audits• Specializing in Software, Design Controls, Production, and CAPAProvide Regulatory assistance • Acting Director of RA/QA at 3 Class II medical device & 2 Class III medical device manufacturers• Assist firms with Regulatory Strategy• Develop 510k and PMA submissions – Sixty-three 510k, one DeNovo, and two PMA submissionsDevelop, implement, and maintain Quality System compliance programs and proceduresProvide Verification/Validation assistance – Protocol and Report creation• Packaging, Stability, Integrity – In-house testing facilities• Biocompatibility/Sterility/Cleaning• Design/Process – EquipmentProvide production, regulatory and quality compliance due diligence observations for merger and acquisition

Medical software consulting company specializing in software risk analysis, validation and FDA submission.

President of a real estate management firm. Abacus owned and ran several multi-family rental properties.

FounderDevelop enterprise-wide operational systems for a wireless PDA-based DICOM WorkstationDevelop regulatory and production strategy Participate in venture financing Participated in sale of company after only 8 months

Founding member of Zmed. Zmed developed a novel stereotactic radiosurgical device that allowed for highly accurate delivery of radiation. Devices included both intercranial therapy and stereotactic body radiotherapy. Developed enterprise-wide operations system and corporate structureManaged all Operations (on-site and off site) and sustaining R&DParticipate in developing short and long term policy and strategic plansProvide direction and structure for operating unitsImplement programs to attain business plan goals for growth & profitCoordinate activities for all product launches, installation, and distribution Managed all supplier activities$12m in Sales in less than 2 years; sold company

Marlborough, Massachusetts, Us

Perform Quality System audits and assessments for compliance to FDA regulations, ISO and EN StandardsSupport manufacturer’s corrective action plan development, and system implementation to achieve FDA/ISO complianceAssist manufacturers and suppliers in developing, implementing, training and maintaining Quality System compliance programs and procedures (specializing in Design Controls, Risk Management, and Process Controls)Provide engineering assistance to manufacturers in developing and maintaining product design and process validations and procedures, design controls, verification studies, risk analysis, equipment qualification, and process capability studies

Managed Quality DepartmentConducted software, biocompatibility, bioburden, sterilization, process, packaging, and design validationsParticipated in three ISO audits and two FDA inspection, Helped devleop one PMA and two 510(k) submissions

New Brunswick, Nj, Us

Managed introduction of the PFC Ceramic Hip Head projectManaged European manufacturing program and factory set-up of the PFC Orthopaedic Hip Stem/Cup system in a new factory in New Milton, England• Project launched one month early and within budget, • Managed international cross-functional team• Purchased and developed new equipment, machining processes, documentation • Managed vendor relationshipsManaged introduction of an Orthopaedic Hip Stem replacement system to the market• Set-up and oversaw project schedule and 3.1 million budgetManaged project to bring family of injection molded components back in-house

East Hartford, Ct, Us

Ensured Design for Manufacturability by working with Design Engineering, Manufacturing Engineering, and Manufacturing.Assist Manufacturing Engineering with manufacturing problemsInvestigate military and domestic engine failures for design and manufactuirng issues

Mba, Entrepreneur

Msme, Manufacturing

Bsme, Mechanical Engineering

Master Of Engineering - Meng