Kolabtree Services and Case Studies - Verdict Medical Devices
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Kolabtree Services and Case Studies

Case Study 1: Statistical review of pre-clinical study

The Challenge:

Alandra Medical, a Mexico-based medical company had just finished a pre-clinical study which tested the safety and efficacy of their medical device. They were looking for a statistician to verify if their results were accurate and help them develop a report for publication.

How Kolabtree Helped:

After posting their project on Kolabtree, the company received 14 bids from expert statisticians within 5 days. They hired an experienced biostatistician, who conducted a statistical analysis, interpreted the data and edited the manuscript. The client awarded the freelancer a 5/5 rating.

Case Study 2: Help with medical device innovation

The Challenge:

Jon P. Mendelson, Chief Operating Officer at Chemo Mouthpiece, a US-based medtech company, had developed an oral cryotherapy device to help cancer patients manage the side-effects of chemotherapy and radiation therapy. He was looking to launch his product in the market. However, he needed supporting documentation for his product, including a compilation of all relevant research articles, clinical trials, and a summary of outcomes.

How Kolabtree Helped:

After posting his requirement for a scientific writer on Kolabtree, Jon received 2 bids within 24 hours. He chose to work with Dr. Kiranam Chatti, a highly experienced scientific writer from India. Kiranam put together a comprehensive report in the required format. Jon then used the report to effectively position and sell his product in the market. He also rehired the same writer for another project.

Case Study 3: Develop a medical device

The Challenge:

A Sydney-based organization providing innovation support for medical device manufacturers was looking to create a new product. They were scrutinising for an expert who could help them formulate the product.

How Kolabtree Helped:

The client posted his project on Kolabtree and received 3 bids within 24 hours. After discussing his requirements with each freelancer, he chose to join up with Andres Alberto Arrocha Arcos, a Mexico-based scientist with experience in nanotechnology and electrochemistry. The client and freelancer worked jointly and the project was completed in a month. After funding the project, the client released 50% of the budget halfway through the project, and the rest after it had been completed.

Services Offered

Clinical Evaluation Report (CER)

Consult top freelance clinical evaluation report writers with 5+ years of experience having expertise in clinical evaluation documents writing, clinical study reports, clinical evaluation statistics  and more.

Medical Device Regulation (MDR)

Our freelancers have helped medical device manufacturers of all sizes achieve regulatory compliance. Speak to an expert directly for help with MDR gap assessment, CE transition, EU MDR compliance checklists, MEDDEV 2.7/1 rev 4, clinical evaluation reports, technical documentation, and more.

FDA submissions

Applying for FDA approval can be nerve-wracking but consulting with experts who have a detailed knowledge of FDA procedures can streamline the process. Hire top FDA submission experts for help with regulatory writing to increase your chances of approval.

510(k) submissions

Consult top 510(k) submission experts for help with FDA submissions, technical documents, and more. Get help from top-rated regulatory writers with experience in medical devices, biotech and pharma.

Regulatory writing

Consult top freelance regulatory medical writers with expertise in clinical regulatory writing, regulatory writing services, and more. Get end-to-end support for developing and submitting applications for approvals, whether they are FDA applications or NIH SBIR grants. Get all the technical documentation you need to get a CE mark.

Regulatory Compliance

Hire CER and Meddev 2.7/1 rev 4 experts for compliance with EU MDR. Work with experts for literature search, gap analysis, EU MDR 2017/745 compliance reports.

Medical writing

Consult qualified and experienced freelance medical writers to communicate your product features and benefits to your target audience. Get help to write content on various topics like pacemaker, ultrasound, medical implants, wearables, catheter, ECG, collagen and more.

Blog/Article writing

Get expert help with SEO friendly medical content writing, editing, fact-checking and more.Services offered – article writing, expert review, CME writing, medical communications.

Other services that we provide help with:

Take your medical device to market easily with the help of our global pool of experts. Get help with all the technical documentation you need to get a CE mark. Qualified and experienced freelancers ready to help you with various services like: IVDR, ISO 13485, Medical device literature reviews, IDE, Diagnostic imaging, Medical device development, ISO 14971 and more.

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