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knoell USA - Medical Devices, 1633 W Main Street/Suite 700, Lebanon, TN (2026)

05/14/2021

The success of the clinical aspects of a medical device is essentially related to its functional properties, which are associated with the design and mechanical characteristics of materials.

When classifying a medical device as biocompatible, it should be made of materials compatible with biological tissues, cells, and bodily fluids based on its clinical intended use. Therefore, the preclinical evaluation of products and their constituents is essential in order to be able to declare it biologically safe before commercialization.

And how is biocompatibility evaluated on a medical device?

One of the main standards to be followed is the ISO 10993 series, laying down requirements for medical devices depending on their type and duration of contact with the patient. The starting point for any evaluation is the physical and chemical characterization of the device and the materials it is made of. It is essential to put special emphasis on the choice of raw materials right from the start – that might save you time and money during the life cycle of your device.

Depending on the results, additional test such as cytotoxicity, sensitization, irritation, implantation, etc., may become applicable.

Throughout the process, it is crucial to link all related activities with your risk management process, whether in the design, manufacturing or post-market stage (e.g. when changes to your device become necessary).

Does your company want to know more about biocompatibility? We have a team of experts ready to assist you! Get in touch with us through the e-Mail: [email protected]

05/06/2021

The stent is a metallic, expandable tubular medical device. It is introduced into the coronary arteries in case of stenosis, which is a condition caused by coronary artery disease.

This disease is characterized by the accumulation of fat on the internal wall of the coronary arteries, which over time forms atheromatous plaques, thus causing the narrowing or obstruction of the affected artery.

This disease can be treated through coronary angioplasty, a procedure with or without stent placement.

In this case, what medical devices are available for the treatment of coronary artery disease?

1. Bare metal stents (BMS);
2. Drug-eluting stents (DES);
3. Bioresorbable vascular scaffold (BVS);
4. Drug-eluting balloons (DEB).

Does your company need to register medical devices in the field of cardiology? Contact us through the e-mail: [email protected]

04/30/2021

Meet our knoell expert Camila Campos.

Camila is biomedical engineer, specialist in medical device regularization, her main experience is with product registrations in ANVISA, the Brazilian Health Regulatory Agency.

During her education, Camila had contact with biomaterials applied to the health area, studing materials characterization guided by ISO 10993 series and applicable legislation focused in the medical devices field.

Currently, Camila is a master student of medical devices and her research applies to the evaluation of stem cells, spheroids and biomaterials in 3D bioprinting for use in artificial organs aimed at regenerative medicine.

"One of our goals at knoell is to support companies of medical devices with cutting-edge science and innovation for the market, this is why we count on the qualification of our experts."

04/29/2021

Concluding the topic about indicators, today we will exemplify how a good indicator works.

Have you ever heard about OKR - Objectives and Key Results? OKR is a tool that tracks progress, creates alignment and encourages engagement around measurable goals. It is a methodology that assists the companies to align the objectives and ensure everyone is working collaboratively.

The OKR is a simple process of setting and connecting the company's goals and the team around them. Each objective is linked to the key results, so that the progress is measurable. The results can be measured on a scale or numeric unit. Objectives are supported by the plans, or weekly initiatives, that will forward the progress.

In summary, OKR is set based on the three parameters below:

- Objectives: a qualitative element;
- Key results: a measurable element;
- Plans: actions and initiatives that move the objectives forward.

Do you want to know how indicators can contribute to your company's growth? Get in touch with knoell USA Medical Devices team. We are ready to serve you.

04/23/2021

Continuing the topic about indicators, today we will talk about how is the selection process of a good indicator for your company.

First, it essential for the company to establish a clear connection between the goals and key results for the organization. Indicators must communicate with the company's objectives.

And how a good indicator is chosen?

A good indicator is reliable and continuing measurable. A good choice is indicators that point out an index or rate instead of qualitative values. Always keep in mind that simplicity is a relevant aspect when defining significant metrics because choosing a high number of indicators can turn to an obstacle to handle, contributing to a non-practical generation of results.

Is it interesting to read about indicators? So, do not miss our next post! We will approach more content about this topic. You can always count on knoell USA Medical Devices team.

04/22/2021

In the current environment, technology is indispensable to the business world, a factor that demands innovation and flexibility. In the medical devices field, the companies are living a particular moment with the demands created by the pandemic of COVID 19. They are striving to deliver quality products in a faster and efficient way.

The big question is: what is the best way to measure performance?

An appropriate system of performance indicators allows the conduction of a deeper and comprehensive analysis of the created goals and achieved results, and how to manage both.

Therefore, it is essential to have a systematic, structured and measurable indicator. Besides its basic characteristics, some specific aspects of the medical devices area should be considered. They are:

- The set of rules and regulations that should be followed under all circumstances. Every country has the particularities related to the quality and regulatory aspects;
- Pre and post-market information about the product must be collected and stored;
- As important as the profit, the safety of products is crucial so that the companies must be aware of all the adverse events related to the product.

In the next few days, we will continue this topic about indicators. Stay tuned! We have a lot of good information to offer! knoell USA Medical Devices has a team of experts ready for your company!

04/16/2021

De Novo is a risk-based classification process for novel medical devices where no substantial equivalent device can be found but where the risk associated with the product does not justify a class III designation.

The De Novo classification process is the Evaluation of Automatic Class III Designation, which was achieved in Food and Drug Administration Modernization Act of 1997 (FDAMA). The Automatic Class III Designation is an alternative for devices that do not have a predicate device, so that they are automatically classified into Class III and would thus be subject to a Premarket Approval (PMA). In order to avoid unnecessary efforts for devices for which general controls or general and special controls are deemed appropriate to ensure safety and effectiveness, the De Novo classification has been established.

And how does the De Novo classification work?

Companies seeking a path to market via the De Novo classification process should submit a request including a description of the device and detailed information and reasons for any recommended classification. After the submission, FDA should make a classification determination by a written order within 120 days of the request. The granting of the De Novo request allows the device to be marketed immediately.

Does your company want to know more details about the De Novo classification process? Count on our team of experts! We are ready to customize the best regulatory strategy for your company!

04/13/2021

The European Database on Medical Devices - EUDAMED is a database managed by the European Commission and has the main purpose of improving transparency and traceability medical devices when placed on the Union market. This database works in conjunction with seven other electronic databases, including UDI (unique device identification). Considered as a multipurpose system it is not only used for notifications and registrations but is also used as collaboration platform for regulatory stakeholders.

That being said, who will have the right to access EUDAMED information?

- Member States' Competent Authorities and the European Commission; these with no limitations;
- Notified bodies, economic operators (manufacturers, authorized representatives, importers and distributors), sponsors and the public; to a limited extend.

An important premise is that the nomenclature used by EUDAMED is internationally recognized and must be accessible to all stakeholders.

Do you want to know more about the regulatory and strategic importance of EUDAMED? Get in touch with our team of experts. We are ready to serve you!

04/09/2021

In view of the importance of the Unique Device Identification (UDI) system, both in the USA and in the Europe Union (EU), advances have occurred with respect to security, feasibility and traceability of the medical devices.

In essence, what makes the UDI system relevant for the medical device market?

- The transparency and traceability of medical devices;
- The improvement of the patients’ and users’ safety;
- The improvements in regards to post-market surveillance.

How the UDI system has been implemented in the USA and the EU?

- In the USA, the UDI is present in the Global Unique Device Identification Database (GUDID), which is administered by the FDA;
- In EU, the UDI is part of EUDAMED - European Database on Medical Devices, which is based on the MDR (EU) 2017/745.

Where requirements for the USA already look back to a longer history, the EU is taking their first but important steps towards the implementation of the UDI. However, be careful, even though the term UDI is used in both regulation, it doesn’t mean you can kill two birds with one stone. Having the USA requirements in place will for sure help you following the EU requirements but covers only half of what is needed.

Does your company need more information regarding the UDI system in the USA and the EU? Contact one of our experts of knoell USA Medical Devices by e-mail: [email protected]

04/06/2021

Continuing our journey on Unique Device Identification UDI and its relevance for medical device market.

Today, we are focusing on the four inseparable elements; each UDI system must be composed of in order to be able to improve the safety of patients.

1) Generation of the UDI by entities: UDI is an alphanumeric code that contains standardized information and follows a formal identification for each medical device on the market;

2) Fixation of the UDI by the manufacturer: the UDI code must be fixed on the medical device itself or on its packaging in a form legible for people and machines;

3) Registration of the UDI by operators: manufacturers, authorized representatives, importers and distributors should have, preferably, electronic control over what was and what is being provided;

4) Establishment of a UDI database: the generation and setup of a UDI alone are not sufficient to increase the overall traceability of medical devices. Therefore, an appropriate database must be made accessible to all stakeholders and the public across the European Union.

Do you want to know how your company can adapt to this new requirement? Count on our specialized consultancy. Our teams and partners are ready to assist you!

04/02/2021

The core concept of a Unique Device Identification - UDI system is to achieve a globally harmonized approach. Currently, the UDI is being implemented in different countries, including the EU and the USA.

The UDI is intended to provide a single and harmonized system for the identification of medical devices and their key attributes. The ultimate outcome of the UDI implementation is an improvement and optimization of the patient's safety.

That being said, the purpose of the UDI system is achieved through the following points:

- Adequate identification of medical devices;
- Efficient traceability from the manufacturing process to the final user;
- Effective field safety corrective actions;
- Reduction of medical errors; and
- Proper documentation of data on medical devices.

Does your company need to optimize its processes for the implementation of a UDI system? Get in touch with our team of experts. We are ready to serve you!

03/30/2021

Not all heroes wear capes – happy Doctors’ Day

National Doctors’ Day is a day to celebrate the contribution of physicians who serve their country by caring for its’ citizens. The holiday first started in 1933 on March 30, which was the first anniversary of a doctor using ether anesthesia. Today we continue to celebrate medical advances like these and thank all doctors everywhere who have spent so much time and energy mastering their field of expertise.

Our team at knoell is delighted being able to bring in regulatory expertise when new medical devices are developed to make sure, great innovations of doctors can be brought to market and eventually benefit patients.

This national doctors’ day, we at knoell Medical Devices are proud to honor the dedicated physicians all around us, and offer our respect, gratitude and appreciation to doctors everywhere. For their care, their expertise, their compassion, their courage, and for all they sacrifice for their patients, especially in the light of the current pandemic. Thanks to doctors and all frontline workers everywhere, there is hope for a healthier future.

knoell USA - Medical Devices

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