Design and Implementation
With extensive experience in creating and implementing new medical technology Vitelon can provide full service from design, test and implementation as well as regulatory support in order to accelerate medical device delivery to the end customers.
Design Control Process
Design and development of a medical device is one of the most important steps to your product success. A loosely-defined and designed medical device has no chance to comply with regulatory requirements and make it to the market.
Having an experienced team in various medical device designs as well as leading innovative Medtech projects, we understand that medical device development is more than just conceptualizing a solution, developing a prototype and pushing to the manufacturing stage. That is why we’ve created our own framework for design and development of medical devices. Although we are not manufacturing medical products, our team gained an extensive experience in that field, so our customers can be sure that manufacturability is one of our main focus point during design.
We use waterfall method as a base for our design process , it makes it transparent and easy for our clients to understand, regardless the quality control system they are using (ISO13485 or FDA 21 CFR 820.30 including CGMP).
Testing Verification Validation
During development process we verify and validate if our design meet the functionality, usability, reliability as well as safety objectives setup by customer and regulatory requirements. Our approach aim to ensure that the device is aligned with the need of target users and it delivers intended functionality. We can deliver devices with wide range of complexity. Every device go threw rigoristic test and validation based on regulatory and international standards. Very often we develop our own testing rigs in order to provide full testing and validation for the most demanding projects.
Risk assessment
While developing new medical device Vitelon is also preparing framework for risk assessment of a design. It is necessary in order to comply with risk management procedures for medical devices as they are enforced under internationally accepted compliance standard ISO 149711:2007 Medical Devices – “Application of Risk Management to Medical Devices”. Apart from this, risk management policies need to be incorporated across all the stages of medical device design and development and should be also associated with design control aspects as well. It is usually done with close collaboration with the client to ensure every aspect of a potential risk is assessed and controlled.
Regulatory and certification support
In order for a medical device to be approved on a given market, the manufacturer must meet certain conditions, most often a certificate is required. Currently, the Act on Medical Devices z on May 20, 2010. The Act adapts the regulations for medical devices applicable in European Community. In the European Union, regulations for introducing medical devices into the marketing are specified in the directives for medical devices: 93/42 / EEC – MDD, 98/79 / EC – IVDD and 90/385 / EEC. These regulations have been in force for several years. Work on the new system is currently underway legal regulations for medical devices in Europe. Two draft Regulations have been prepared Of the European Parliament, defining respectively the regulations for medical devices and for in-vitro diagnostic medical devices. It is expected that these legal acts will remain introduced in 2016/2017. Harmonized standards are related to the system of directives for medical devices. These standards define detailed technical requirements that translate into specific solutions, adopted in the product itself and in its production processes. These regulations also relate to requirements for quality management systems. An additional, very important aspect is the clinical compliance of devices. Producer of the product medical professional is required to provide appropriate clinical evidence to show that the defined purpose and method of use of the product comply with a recognized level of knowledge. And, that the benefits of using the device do not exceed the risk to the patient. In EU countries, regulations including the scope is specified in the Regulations of the Minister of Health, adapting European documents MEDDEV. In the case of particularly risky devices, such as implanted and using devices innovative technologies, clinical trials are required for their introduction to the market. For all higher risk medical devices, i.e. for medical devices classes Im, Is, IIa, IIb, III, active implanted medical devices and diagnostic devices
in-vitro products listed in Annex II to Directive 98/79 / EC and self-testing devices, participation of a notified body in the assessment of product conformity is required. This participation varies in scope, depends on the level of risk of the product. Detailed conformity assessment procedures, including participation a notified body is defined by the directives for medical devices. Vitelon team members have extensive experience in certification surgical equipment as well as electronics and software solutions therefore we can provide support in every step of the process.
