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Surgical Loupes

Medical Devices

Medical device development presents unique challenges to companies seeking approval of novel products. Increasingly impacted by regulatory measures, new technologies, and healthcare economics, companies developing new devices require a disciplined approach to succeed.

Patient and subject-reported outcomes as well as experiential data are now required endpoints for certain regulatory approvals in vaccines, epilepsy, migraine or Crohnís disease. Additionally, biomarkers, subgroups, and other response predictor models derived from trial or real-world data offer more informed guidance on subsequent trial designs, mitigating future study risks.

Image by Memento Media

Successful product development paths are often guided by thoughtful regulatory, economic, and development strategies, as well as meticulous detail to clinical trial execution. From the first stages of getting your device classified by regulatory authorities through market surveillance on your approved product, our team of experienced professionals can help you mitigate risk by navigating regional or global regulations that apply to your device.

Medical Device Services

BioFicher offers a variety of global development and commercial services to help advance your medical device from development to commercialization.

Development and Testing

Developing medical devices and testing them requires specific expertise and experience. Fortunately, we can be your ultimate resource for all services related to these critical aspects of the process. We have the knowledge necessary to guide your project through the initial stages of design through the clinical trials. We will be your full-service global CRO through every step of the way, including the preparation and filing of all regulatory documents that pertain to your specific markets.

Our capabilities as medical equipment manufacturers can ensure that the medical instruments and other products you bring to market will have been fully vetted and verified to be safe and effective for use by physicians and patients.

Here is an overview of all the services we can provide during this stage of the process:

  • Phase I-IV clinical trial management

  • Protocol development and study design

  • Site monitoring services

  • Drafting investigational plans

  • Data collection, management and analysis

  • Development of the pharmacovigilance system

  • Statistical analysis and reporting

  • Regulatory consulting and strategy

  • Preparation of all essential regulatory documents

  • Regulatory filing and publications

  • Communication with regulatory authorities and ethics committees

  • EU Authorized Representative

Image by CDC

CE Marking

Image by National Cancer Institute

To successfully market medical devices throughout the markets of the European Union, it is necessary to obtain the CE marking. This affirms that the device in question complies with all EU regulations. Our experience in CE marking ranks among the best in the industry, meaning we are your top choice for medical device manufacturers wanting to market their products overseas.

Below is a summary of everything we can do to help ensure medical devices for sale in the EU conform to all requirements:

  • RA/QA Consulting

  • EU Medical Device Classification

  • EU Authorized Representative

  • Technical File Compilation

  • Clinical Evaluation Reports

  • Post-marketing surveillance

  • ISO 13485 Implementation

Sample of BioFicher’s Medical Device Experience

Image by Richard Catabay

  • Laser systems for glaucoma

  • Minimally invasive glaucoma shunts (MIGS)

  • Influenza vaccine/device combination

  • Advanced macular degeneration monitoring device

  • Diabetic retinopathy AI software

  • Reagents for ex-vivo T-cell depletion for GVHD

  • Drug coated balloon PTA catheter for treatment of dysfunctional native and synthetic AV fistulae

  • VytronUS ablation system for treatment of symptomatic drug-refractory paroxysmal atrial fibrillation

  • RemedÄ“® system in patients with central sleep apnea

  • Tempered infusions for induction and maintenance of normothermia in refractory febrile patients

  • Catheter ablation vs. standard treatment for left ventricular dysfunction and atrial fibrillation

As one of the leading CROs in the industry, we have the qualifications and experience needed to benefit your medical devices company. We have successfully helped develop and test everything from medical alert devices to implantable technology. Our dedication to the highest standards of clinical safety and pharmacovigilance means you can have peace of mind when working with us.

We have completed more than 1,000 clinical studies since 2017, and our knowledge base covers a broad range of therapeutic areas. We share the knowledge we have accumulated on the private and public side of the industry to better serve our clients.

To learn more about everything we can do for your medical device development process, get in touch today.

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