Tsunamed was launched in January of 2010 following a successful business expansion project and utilizing our manufacturing partners with over 15 years of production and development expertise in Germany. Tsunamed provides end-to-end solutions.
QualiMed was founded in 1997 as an OEM and private label manufacturer for implantable medical devices and is based in Winsen, Germany. Our primary focus is to create an alliance of global distribution partners and their associated physicians, to develop new technology with existing products for the patients they treat. By aligning ourselves with world key opinion leading medical practitioners in Interventional Cardiology, Peripheral Vascular and Non Vascular Specialties, we aspire to create medical devices “Created by Physicians for Physicians.”
The company has created a 12 Step process to take products from Ideation through to manufacturing and commercialization. The approach lets the companies team assess new ideas, market conditions, competitive landscapes, and current technology including IP in an effort to determine the viability of various technologies and partners it would choose to bring products through the commercialization and sustaining engineering life cycle.
The company’s Research and Development Department is focused on taking ideas through all phases of conceptual development. During the Ideation Phase the company documents the initial concept or idea that needs to be explored in detail.
During the initial design phase and throughout the product lifecycle the company utilizes an extensive literature review process to assess existing product outcomes and modalities to insure proper user needs identification based on key critical to quality parameters based on complication rates and success rates established in the historical literature.
During the feasibility phase the company along with its partners assess the real market opportunity for the technologies success based on a number of critical elements the company has established to insure that development achieves its respective levels of success.
The company uses the Design Input Specification phase of its development methodology as a risk mitigation tool to assess the required design inputs to achieve the appropriate design outputs based on key user needs specifications. These key user needs are then validated by the literature review, feasibility assessment, and expert user input to insure the greatest opportunity for meeting the requirements of the initial Idea.
During the regulatory assessment phase the company utilizes its extensive staff of regulatory personnel to evaluate the global regulatory needs to launch the devices commercially while linking these commercialization requirements to the specific testing that will be utilized during development up to the initial regulatory approval.
The risk analysis phase is used to accurately reflect and document the product risk for each of the parameters to insure that all the participants are focused on what the company terms its Tri-Level risk mitigation methodology to minimize any external risk that could jeopardize the development or time lines.
During the Design Output Specification Phase the company establishes and maintains procedures for defining and documenting design output in terms that allow an adequate evaluation of conformance to design input requirements. The Design output procedures shall contain or make reference to acceptance criteria and shall ensure that those design outputs that are essential for the proper functioning of the device are identified. The Design output is documented, reviewed, and approved before release while the approval, including the date and signature of the individual(s) approving the output, are documented.
The company utilizes a three stage prototyping process to insure that the user needs specification are achieved in the design output specifications.
Bench testing is an essential element to insure that the user needs specifications are met as defined in the design input and output specifications. The bench testing is established to accurately assess whether the design meets the user needs requirements.
The company uses the animal trial phase of the development process to further validate that the user needs specifications are met through the design inputs and validated in the design outputs. The company has the capabilities to manage the animal trial process from the protocol writing to testing of the technology through various partner facilities throughout the world.
The company will assist its partners in validating the designs through rigorous clinical testing of the technology and can assist or run the clinical studies as desired by its partners with a focus on generating the data required to achieve regulatory approval for the technology globally.
The company has established a manufacturing skill set to produce high quality implantable technology and catheter based applications though its ISO 13485:2012 and ISO 9001:2008 certified facility and through its global manufacturing partner relationship in Asia, Europe, and North America.