JK Medirise sees opportunities in Latin America and Africa

Brückenkopf recently interviewed with Mr. Ketan Munjani, Marketing and Sales Manager at JK Medirise.

(Q: Question from Brückenkopf GmbH / A: Answer from Mr. Ketan Munjani by JK Medirise)

Q: Mr. Munjani, what is your current portfolio? We understand that your company is a reputable medical device manufacturer, which categories do you focus on?

A: Our company was incorporated in the year 2012, we manufacture Single Use Medical Devices for transfusion & infusion, urology and cardiology purposes. We also deliver anesthesia, surgery, gastro-enterology, and surgery dressing products, and our product lines are expanding.

Q: What are the major markets of your company? The domestic one or international market?

A: We identify the precise need of the client related to the product and delivers products following international quality standards. We serve the international market in the worldwide healthcare sector, and we have obtained and maintained very strong international reputation.

Q: Do you have R&D capabilities of your company, or do you co-operate with third parties?

A: Our company has highly qualified and skilled team members who work in professional environment in the work place. R&D is important to the company. We have our own R&D capabilities but at same time we also work with third parties in terms of R&D to offer the most accurate and reliable products to our customers.

Q: How do you manage product quality control of your products? Do you hold any quality certifications to your products?

A: Yes. We have ISO 13485 Certificate & CE Certificate. In our company quality holds the top priority. Every item passes through strict quality checks at various stages before they are finally approved for delivery.

Q: What do you see as challenges and opportunities in the market in 2017?

A: We foresee new innovative Product as challenges, and we think there are vast opportunities in Latin American and African countries for our range of product. As an international oriented company, we evaluate our success by keeping the aspects of our customers, physicians or healthcare professionals together, as they are the ones whom we are working for.

Background info of JK Medirise:

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UNFO Med can help infants suffering from MTA

Brückenkopf recently interviewed with Mr. Dr. Izak Daizade M.D – founder and R&D Manager at UNFO Med, who offers innovative device to treat newborns afflicted with congenital foot deformities.

(Q: Question from Brückenkopf GmbH / A: Answer from Mr. Dr. Izak Daizade M.D by UNFO Med)

Q: Mr. Dr. Daizade, could you please explain which sector is your company specialized in?
A: I am the founder of UNFO Med, and I have more than 35 years of experience in pediatric surgery. UNFO Med. Ltd. is a healthcare company specializing in the orthopedic field, we are a manufacturer of the revolutionary Universal Neonatal Foot Orthotics system.

Q: What are the major markets of your company? Only in Israel or also the international market?
A: We work in the international healthcare market. The UNFO Med system has obtained patent in the United States and China and patent pending status in Brazil, Europe, Canada, Australia, India. Our expert team works very hard to develop new and innovative treatments aimed at bringing relief to thousands of suffering infants afflicted with foot conditions and enable them the happy, pain-free life they so deserve.

Q: Do you have R&D capabilities of your company, or do you co-operate with third parties?
A: UNFO Company has his own R&D capability and cooperates with several Orthopedic Centers world- wide.

Q: Dr., What do you see as challenges and opportunities in the market in 2017?
A: We strongly believe in the importance of providing relief to infants and their families, preventing unnecessary pain and suffering, and bringing aid to those who have been labeled as “incurable.” There is currently no specific treatment for metatarsus adductus (MTA), leading to a certain amount of confusion over when and how to treat MTA in infants. The lack of a specific solution for MTA has left orthopedic centers no choice but to adapt the casting technique indicated for club foot.
This casting technique comes with a number of disadvantages and complications. Due to problematic casting procedure in MTA there have been some understatement and compromising attitude about the treatment indications. More and more newborns in the world enjoy the easy treatment of their foot deformity by UNFO, replacing the old problematic technique of serial casting. There is no doubt that most of complications and surgical interventions can be avoided by adequate treatment in the first months of infant life.

Background: UNFO Med company info
UNFO Med Ltd

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Medical Device Reporting for Manufacturers, Guidance for Industry and Food and Drug Administration Staff (FDA)

The guidance outlines manufacturer’s responsibilities for reporting adverse events to FDA. Unless exempted, manufacturers must implement written procedures addressing Medical Device Reporting (MDR) requirements. Guidelines for follow-up investigations and addressing event reports in the medical or scientific literature are included.

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Deciding When to Submit a 510(k) for a Software Change to an Existing Device (FDA)

The device guidance updates FDA requirements for determining when a 510(k) premarket notification is required for device changes. It offers principles and flow charts for assessing label changes, and assessing technology, engineering, performance, and materials changes for in vitro diagnostic and non-IVD devices. Also included are risk assessment considerations, case examples with explanations why a 510(k) is or is not needed, and documentation required if a 510(k) is not needed. The software guidance focuses on how to determine when a software change requires filing a 510(k).

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Deciding When to Submit a 510(k) for a Change to an Existing Device (FDA)

The device guidance updates FDA requirements for determining when a 510(k) premarket notification is required for device changes. It offers principles and flow charts for assessing label changes, and assessing technology, engineering, performance, and materials changes for in vitro diagnostic and non-IVD devices. Also included are risk assessment considerations, case examples with explanations why a 510(k) is or is not needed, and documentation required if a 510(k) is not needed. The software guidance focuses on how to determine when a software change requires filing a 510(k).

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