IQVIA formerly Quintiles & IMS Health Inc.an American Fortune 500 & S&P 500 multinational company.Lifescience suite Clinical Commercial solutions for Global Compliance involving Regulatory Intelligence (RID) Regulatory Information Management (RIM) & Enterprise Quality Management (QMS) & Commercial Compliance provide regulatory & compliance needs.MedTech products services & consulting offerings help companies automate & address vigilance & safety processes.IQVIA MedTech offers unique single-source alternative disparate providers yet integrates well with existing systems & processes.• Pharmaceutical Drug Medicinal Medicine Product Consulting• On-site assessments reviews & mock inspections• Set up operations records & reports• SOP development/reviews• Due-diligence reviews• Customized regulatory training• Statistically derived Significant Loss Threshold (SLT) establishment• Registration/approval process assistance• DEA Suspicious order monitoring & customer due-diligence assistance• Assistance obtaining DEA registrations• Provide strategic consultation on quality Perform mock FDA inspections & Develop & implement systems & GMP/QSR compliance FDA preparedness training quality systems• Conduct GMP/QSR assessments Develop & execute Create & implement & training validation programs corrective action plans • Undertake internal & Investigate suspected fraud Provide strategic direction effectively supplier audits & scientific misconduct managing organizational changes quality systems processes & cultural transitions • From product classification & claims licensing & importation requirements we support you in navigating complex local regulatory environment achieve faster speed market.We leverage unique on--ground expertise scientific KOL networks & proprietary regulatory intelligence databases achieve best regulatory outcome clients.expertise covers various products like Software Medical Device (SaMD) in-vitro diagnostics (IVD) & device-drug combination product

Regulatory Affairs Consultant, Medical Device, FDA, CE Mark, CanadaCONTACT ME:Email: dallas@thomasregulatory.com+1 (561) 898-0260 (Business Phone & SMS Text)http://www.thomasregulatory.comThomas Regulatory Resolutions, Inc. (TRR) is a consulting firm in the FDA Regulatory Affairs, Global Regulatory Submissions (including FDA and European CE Mark among others). Clinical Evaluation Reports (CER) per MEDDEV 2.7/1 Rev 4 and specializing in the medical device space. EU Medical Device Regulation (EU MDR) Transition & EUA UseTRR was founded on the principles of providing LEAN FDA regulatory support to the industry.Medical Device Product Experience:•Sterilization Devices*Emergency Resuscitator / Ventilator/ Face Masks / Surgical Mask/ Surgical Gown / N95 Respirators / PPE / Air Purifiers for COVID-19 SARS-CoV-2 Pandemic•Syringes, Insulin Needles, Hypodermic Needles•Gastroenterology Devices: Radiofrequency Ablation, Cytological Sampling•Patient Spot Monitoring•Electromedical: Vascular / Ophtalmic Ultrasound, Ultrasonic Tissue Cutting incl. some w/ Bluetooth & cybersecurity•Orthopedic Devices: Spinal Fixation Systems, Rods, Plates, Nails, Screws, pediatric•Stent Grafts: Thoracic, Aortic, balloon.•Dental (incl. implants, restorative abutments, surgical tools, digital, custom, mouthpiece, & regenerative allograft bone)•Mouthpiece: snoring, obstructive sleep apnea - OSA•Vascular Access: Implantable Infusion Port - Catheter, Infusion Needle Sets, Vascular Ultrasound, Catheters (PICCs, Dialysis, Drainage), Feeding Tubes•Absorbable and Non-Absorbable Sutures•Ophthalmic Ultrasound (electromedical)•Vision Care Devices i.e. contact lenses•Biosensor devices (i.e. oximeters, etc.)•Wound Care devices•Multi-vital sign / spot checking monitoring system / blood pressure / pulse oximeter / biosensor / heart rate•Dermatology devices•Surgical equipment: reusable surgical instruments, handpieces, motors, ultrasonic tissue removal devices

• Responsible Authoring and Originating multiple first time product submissions with an European EU MDR Focus for class III, class IIa, and class IIb medical devices• Remediation of multiple European Union EU Medical Device Directive MDD 93/42/EEC Technical files to transition to first time EU Medical Device Regulation (EU MDR ) 2017 / 745 Technical Documentation (Tech Docs).• Technical Documentation STEDs compliant with European Union EU Medical Device Regulation EU MDR 2017 / 745• Initiated first time EU MDR Submissions to the DQS EU Notified Body (NB)• Supporting Rationales for Product Development Changes not requiring regulatory submissions and also those requiring submissions based on the change assessments.• Regulatory Signatory and Approver for Cross Functional Testing Protocols, Plans and Reports for Risk Management Documentation, Biocompatibility, Sterilization, Packaging, Labeling. • Labeling and IFU instruction for use and literature review as regulatory signatory• Responsible for tracking, pulling, and attaching documents including test protocols and test reports, justifications, and rationales in the Microvention Document Control System with the WindChill Software.

• Responsible Authoring and Originating multiple first time product submissions with an European EU MDR Focus for class III, class IIa, and class IIb medical devices• Remediation of multiple European Union EU Medical Device Directive MDD 93/42/EEC Technical files to transition to first time EU Medical Device Regulation (EU MDR ) 2017 / 745 Technical Documentation (Tech Docs).• Technical Documentation STEDs compliant with European Union EU Medical Device Regulation EU MDR 2017 / 745• Initiated first time EU MDR Submissions to the DQS EU Notified Body (NB)• Supporting Rationales for Product Development Changes not requiring regulatory submissions and also those requiring submissions based on the change assessments.• Regulatory Signatory and Approver for Cross Functional Testing Protocols, Plans and Reports for Risk Management Documentation, Biocompatibility, Sterilization, Packaging, Labeling. • Labeling and IFU instruction for use and literature review as regulatory signatory• Responsible for tracking, pulling, and attaching documents including test protocols and test reports, justifications, and rationales in the Microvention Document Control System with the WindChill Software.

Medical Device Regulatory Consultant EU MDR

Medtronic medical device regulatory Affairs Consultant for FDA EU MDR Tech Docs

Contract Medical Device Regulatory Affairs and Quality ConsultantContract Consulting across all things regulatory, quality, auditing, and clinical evaluation reports (CERs) for Orthopedic Clients including pediatric, spine, scoliosis, trauma and deformity correction, long bone etc.Medical Device Single Audit Program (MDSAP) TransitionEU Technical File Remediation

Lead Auditor Contracted for Medical Device Clients for Stage I and Stage II Audits for the ISO Registrar for 13485:2016

Contract Clinical Evaluation Report CER Medical Writer & Regulatory & Medical Affairs ConsultantEU MEDDEV 2.7/1 Rev 4European Union EU Medical Device Directive MDD 93/42/EECEuorpean Union EU Medical Device Regulation 2017/745EU CE MARKEuropean Union CE MarkClinical Literature ProtocolClinical Literature ReportClinical EvaluationLiterature DatabaseResearch Database

Contract Clinical Evaluation Report CER Medical Writer & Regulatory & Medical Affairs ConsultantEU MEDDEV 2.7/1 Rev 4European Union EU Medical Device Directive MDD 93/42/EECEuorpean Union EU Medical Device Regulation 2017/745EU CE MARKEuropean Union CE MarkClinical Literature ProtocolClinical Literature ReportClinical EvaluationLiterature DatabaseResearch DatabaseMEDICAL DEVICE REGULATORY CONSULTINGIn today’s market, medical device companies pursuing commercialization need a global regulatory strategy. We offer strategic guidance at every stage of the product development process.Our regulatory experts have specialized knowledge of the many regulatory jurisdictions.How We WorkNAMSA provides regulatory support in multiple ways:Ad hoc hourly consultation and adviceFunctioning as a virtual regulatory and QA departmentProviding emergency response teams for Warning Letter resolution, recall handling or audit responsesCommon AssignmentsRegulatory assessmentGlobal regulatory strategy developmentPre-IDE meeting preparation, including development of pre-meeting packetPre-IDE meeting participationPre-market submissions: 510(k), PMA, BLA, HDEFDA inspection preparationFDA advisory panel preparation and meeting supportOther NeedsThrough the years, we’ve supported hundreds of clients seeking regulatory designations, clearances, and international registrations.

Contract Clinical Evaluation Report CER Medical Writer & Regulatory & Medical Affairs ConsultantEU MEDDEV 2.7/1 Rev 4European Union EU Medical Device Directive MDD 93/42/EECEuorpean Union EU Medical Device Regulation 2017/745EU CE MARKEuropean Union CE MarkClinical Literature ProtocolClinical Literature ReportClinical EvaluationLiterature DatabaseResearch Database

Contract Clinical Evaluation Report CER Medical Writer & Regulatory & Medical Affairs ConsultantEU MEDDEV 2.7/1 Rev 4European Union EU Medical Device Directive MDD 93/42/EECEuorpean Union EU Medical Device Regulation 2017/745EU CE MARKEuropean Union CE MarkClinical Literature ProtocolClinical Literature ReportClinical EvaluationLiterature DatabaseResearch Database

Medical Device Regulatory Affairs Consultant

Medical Device Regulatory Affairs Consultant

7 reasons to choose Emergo1. We Can Help You Access Markets More EfficientlyBrazil, China, Japan, Mexico, Korea...which market is next for you? We help medical device manufacturers strategically leverage their existing regulatory approvals so they can enter new markets quickly and cost effectively. Hiring an experienced consultant with a global view and local expertise is critical. 2. One Call Gets You Access To 95% Of The Global Medical Device MarketThere are hundreds of qualified consultants who can help you with compliance in one or two markets. Emergo can help you prioritize and access more than 55 countries accounting for 95% of the global healthcare spending. 3. We Likely Have Experience With Your Device CategoryWe serve thousands of medical device and IVD clients making a huge variety of products. Our consulting expertise runs especially deep in areas such as orthopedics, cardiovascular, dental, radiology, wound care and IVDs.4. We Give You Full Control Over How You Distribute Your Devices More than 2,000 companies use us as their independent regulatory representative and registration holder. This is important in markets including Europe, Brazil, Japan, Mexico and China.5. Your Intellectual Property Is Safe With UsDo you trust your distributor with your intellectual property? It's an especially critical issue for new and innovative technology. Emergo has nothing to gain by sharing your IP. Others might. 6. We Provide Accurate, Realistic Project BudgetsNobody likes surprises when it comes to invoices. Our consultants all carefully track the number of hours spent on each project and use this knowledge to more accurately estimate new projects.7. We Provide Frequent Updates And Peer Review All ProjectsWe have dedicated project management teams in North and South America, Europe and Asia.

GAP Analysis Audits Audits performed to : FDA 21CFR 820, ISO 13485, Japan PAL, PICs standards and Canadian Standards CMDR. The gap analysis is typically conducted before the implementation of a new quality system or before heath authority or notified body audit.ISO 13485 AuditAudits performed at medical device companies several weeks prior their ISO 13485 certification by their notified body. Full or Partial Internal Audits MEDICAL DEVICE CONSULTINGDefining the correct regulatory strategy is critical as the regulatory landscape is constantly changing and new technologies are being introduced. Medical device companies’ product development through commercialization has become challenging, risky and at times overwhelming.MEDICAL DEVICE REGISTRATIONMoreover, some countries require all registration documents translated into their native language before submission such as China, Korea, Japan, Brazil and Mexico. (GRP) Regulatory Affairs team has the expertise, long-term experience preparing and compiling the registration dossiers for all categories of medical devices and IVDs in line with the latest regulatory requirements in multiple countries before submitting them to the appropriate health authorities.Through many years of operation, GRP has established close working relationships with health authorities in many countries. GRP has developed regulatory and technical skills to assist medical device and IVD companies register their products efficiently anywhere in the world.The GRP RA team has expertise in preparing the following applications:Investigational Device Exemption (IDE) preparation and submissionPremarket Approval application (PMA) preparation and submissionPremarket notification 510(K) preparation and submissionCE MarkingTechnical Dossier preparation and submissionSTED dossier preparation and submission-License renewal (for international markets only)PMA supplements preparation and submissionAmendments preparation and submission

Regulatory Affairs Consultant

Providing expert-level advice to medical device, and life science leadership, institutional investors, private entities and professional services firms on development strategies, meeting timelines, budgets and other objectives and tackling challenges in critical moments, to make informed decisions for multi-million dollar investments and sound and confident business venture decisions for the firms’ short and long-range portfolio strategies.Today, we are the world’s largest membership network for one-on-one professional learning, comprising more than 500,000 thought leaders and practitioners, including business leaders, scientists, academics, former public sector leaders, and the foremost subject matter specialists. We serve users at more than 1,400 client companies in 40 countries. These clients include Fortune 500 companies in nearly every sector and the leading professional services firms and financial institutions.GLG’s industry-leading compliance framework allows clients to learn in a structured, auditable, and transparent way, consistent with their own internal compliance obligations and the highest professional ethical standards. Our compliance standards are a major competitive differentiator and key component of the company’s culture.GLG is headquartered in New York with 22 offices globally and 1,400 employees.Our membership comprises over 500,000 professionals who answer client questions.These questions allow Council Members to share their industry knowledge with leading companies on topics including:Accounting & Financial AnalysisConsumer Goods & ServicesEnergy & IndustrialsFinancial & Business ServicesHealthcareInformation Technology (IT)Legal, Economic & Regulatory AffairsReal EstateTechnology, Media & TelecommunicationsCouncil Members consult with our clients over the phone or in person, through small group meetings or longer-term board or special advisory. Positions and project participation is always at Council Members' discretion.

Medical Device Regulatory Affairs

Global Regulatory Submissions Work.Zimmer Biomet has been based in Warsaw since it was founded in 1927. Today, Zimmer Biomet has operations in more than 25 countries around the world and sells products in more than 100 countries.Our global team designs, manufactures and markets effective, innovative solutions that support orthopaedic surgeons and clinicians in restoring mobility, alleviating pain and improving the quality of life for patients around the world. Our musculoskeletal technologies and a wide range of related products and services make us valuable partners to healthcare providers in more than 100 countries.We're building on a strong history of success to enhance the value we provide to healthcare providers and their patients. Zimmer Biomet maintains world-class scientific facilities and resources and collaborates with leading clinicians and researchers around the world. We share a commitment with healthcare providers to find the best technologies, treatments and solutions to deliver high quality, cost-effective patient care.For nearly 90 years, Zimmer Biomethas been a driving force in the rapidly growing musculoskeletal healthcare industry. With an unwavering focus on the needs of patients and surgeons,Zimmer Biomet is an industry leader.Those who join our team find a stimulating work environment focused on being the best - designing and building the best possible systems and delivering the most robust package of value-added services to our customers. They also become part of a company with a heritage of leadership, a focus on the future and a global presence in an exciting and rewarding medical field.

Latin America Regulatory Affairs Support in Portuguese and Spanish:Product RenewalsProduct SustainingRegistration MaintenanceRegistration FixesFirst Time RegistrationsBrazil-ANVISAArgentina-ANMATColombia--INVIMAUruguay--MSPPeru--DIGEMIDMexico--COFEPRISFDA Inspection, 483, Warning LetterRecertification audits Product complaint backlogInadequate process validationsOverdue CAPAsRisk Management gaps and disconnectsDesign Control gapsInsufficient personnel/resourcesProduct RecallsAnd more… With a single focus on medical device manufacturers, GCI specializes in Quality Compliance Services including:Process ValidationMethod ValidationDesign ControlRemediation of Quality Systems and records, including:CAPA files/recordsComplaint files/records and investigationRisk Management documentationDesign History File remediationTechnical File and Design Dossier updatesProduct and Process ControlsSupplier Quality filesAnd much more…What makes GCI different than the rest?With our proven “Balanced Team” approach, we provide the correct mix of talented biomedical engineers and technical managers to address your regulatory and quality compliance issues. A team of young, tech-savvy engineers, led by one or two technical managers, is a team of roll-up-our-sleeves do-ers. Why hire a team of chefs when what you really need is people to run the food out while it’s still hot? If you’re currently working with, or have worked with, outside experts, ask yourself if they provided a “Balanced Team.”GCI is honored to have partnered with a large number of medical device manufacturers, including global, Fortune 100 customers, assisting them with some of the very same issues you may be facing today. We believe you will find confidence in GCI’s ability to help you with your needs, and we think you’ll agree with our core values and business model.

~Responsible for Regulatory Assessment in Change Requests regarding product design, labeling, IFUs, and translation destined for international markets.~Direct liaison between company representatives in Brazil. Responsible for coordinating and assuring that ANVISA requirements and requests are met in a timely manner and per deadlines. ~Responsible for coordination of INMETRO certifications for Medical Imaging products per IEC 60601-1, IEC 60601-2, and IEC 60601-2-37.~Responsible for product sustaining work for CE Marked products in the European Union.~Member of Corporation-wide committee on International Product submission dossiers and assisted as Division liaison to the committee to ensure that feedback from all country specialists was incorporated.~Trained new coworkers on company systems, protocol, and best practices.

Successfully drove and completed multiple International Dossier Submissions for First Time Registrations of various product families in the markets of Brazil, China, Mexico, and other Core Markets.Maintained direct contact with company representatives around the globe.Worked directly with our Portuguese and Spanish Speaking Counterparts in Brazil and Mexico in order to ensure efficient and productive product submissions, renewals, and sustaining work.Successfully CE-Marked Medical Devices for Market in Europe.Responding to deficiencies from ANVISA (Brazil) and COFEPRIS (Mexico).

Assisted with 510K ActivitiesCreated Rationales in conformance with US FDA 510K regulations.Created and submitted product change notifications to various global geographies.Supported creation of Regulatory Database in order to provide more efficient and productive data management.

~Managed up to 20 Associates in a sheltered workshop retail environment.~Trilingual associate support and customer support.

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