Intellex Acquires Expert by Big Village

We're thrilled to announce that Intellex has acquired Expert by Big Village, effective March 22, 2024. This strategic move enhances our capabilities and strengthens our commitment to delivering exceptional solutions to our customers.

Stay tuned for more updates on how this acquisition will benefit our clients and experts.

For inquiries or more information, please contact us at info@intellex.com.

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ID: 726245 Minnesota, USA

Implantable and Non-Implantable Medical Device Risk, Safety, and Failures

He has experience in developing, writing, and submitting risk management related documentation to support Notified Body, 510k, PMA-S, and PMA submissions (Class I, II, and III). He has experience in the legal and safety requirements between 510k and PMA devices…

ID: 726193 New Jersey, USA

Medical Device Design and Analysis

He was responsible for providing product data for 510(k) submittals. He was responsible for developing devices and technology for patient gas monitoring devices, cardiac monitoring devices etc. He was responsible for the development of several defibrillators. He was responsible for…

ID: 726036 Minnesota, USA

Medical Device Research and Development

Expert has over 30 years experience in medical device design dealing with all phases of design -- brainstorming, concept design, proof of concept testing, prototyping, cost / task estimating, project planning, project management, detailed design, bench testing, troubleshooting, design verification…

ID: 725917 France

Medical Device Technology, Clinical Research & Business Development

Expert has decades experience in Multi-modality medical imaging: digital x-ray, ultrasound, IVUS, MRI, intra-operative MRI, multi-slice and cone beam computed tomography, hybrid PET/CT and SPECT/CT, optical coherence tomography (OCT), endo-confocal microscopy and fluoroscopy imaging. Furthermore, he has experience in Image-guided…

ID: 725382 Tennessee, USA

Biomedical Engineering, Patents, Medical Device Design, Product Development, Eye Activity Devices

He has served as a consultant as well as trained and led numbers of team consultants in application software development projects for over 20 years. Masters Degree specializes in optics and diagnostic/remediative processes and devices based on eye activity. PhD…

ID: 725331 California, USA

Medical Device Regulatory Submissions

She has extensive experience writing and compiling 510(k)s and PMAs for product clearance or approval with a well-established track record of success. Some of the device types she has experience include Surgical Instrumentation, Cardiac Ablation Systems and Catheters; Surgical, Ophthalmic…

ID: 725163 Florida, USA

Medical Device Regulatory Support, Medical Device Registration, etc.

Expert is a Regulatory and Quality Consultant with strong team building skills for high technology corporations. A hands-on career of increasing leadership positions with a broad range of responsibilities in manufacturing, regulatory affairs and new product introductions. A committed professional…

ID: 725158 California, USA

Medical Devices, In Vitro Diagnostics Design, Quality Control, Trouble-Shooting, etc.

Expert has authored and submitted 510(Experts for more than 25 IVD (In Vitro Diagnostics) products. These 510(Experts encompass a variety of IVD products from manual, semi-automated to fully automated non-isotopic diagnostic tests including point-of-care devices. Expert has the expertise to…

ID: 725088 California, USA

Medical Devices, Electronic Systems, Acoustics and Hearing, Intellectual Property

Because of his long-term interest in sound and hearing, Expert has been involved with many aspects of acoustic measurement. He has developed proprietary technology for sound level measurement and noise dose determination and has utilized his skills in acoustic measurement…

ID: 725075 Minnesota, USA

Orphan Drugs: FDA/EU/Canada; FDA Approval; Drug Development: CMC, QA, QC, Manufacturing

12 product approvals from FDA including 6 new chemical entities, a 510k device, and three major pharmaceutical efficacy indication supplemental approvals. All received 5-10 years of regulatory exclusivity (Hatch-Waxman, Orphan Drug). These products are generating over $100 million dollars in…

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