Li-Med quickly and cost effectively plans and implements quality systems that fully comply with regulatory directives.
Whether you are an established company or a startup taking its first steps, we will ensure that a well-planned quality system is in place.
We work with you every step of the way and tailor our solutions to meet your specific needs. We are flexible and can offer as much or as little support as needed.
We offer the following services:
Every device needs a clear roadmap to market. A proactive approach to regulatory issues helps to ensure that your product reaches markets on time and without delays.
We work with our clients to develop a sound regulatory strategy that meets its objectives and aligns with the company’s business plan. Faster access to market and to revenue builds profitability and paves the way to continued success.
Sometimes you need ad-hoc or even long-term assistance with your quality and regulatory affairs management but do not want the overhead associated with hiring additional staff. We can help you add to your team highly qualified outsourced personnel to manage regulatory and quality control issues - on a temporary or ongoing basis, part-time or full-time.
The European CE Mark shows that the products manufactured by a company adhere to all the relevant directives and standards that are used to determine compliance. Its advantage is the ability to sell products throughout the European community and is the stepping stone for marketing in other international markets as well.
Preparation of the CE dossier can be cumbersome and may comprise many different documents. These include templates, reports, charts and graphics in various disciplines. We can help you find the best route to approval and prepare all the pertinent documents for you.
Having a quality system and regulatory approval for your product is not enough. In order to ensure that your system is both compliant and effective, you need to constantly monitor in order to identify deviations that should be corrected. A gap assessment audit can find flaws in internal processes (including on site audits that assess if your employees are aware of and working according to required standards), and external processes (checking that your subcontractors are working according to standards). We have a team of professional medical device experts with experience in quality standards and regulatory compliance who can help you prepare for any audit.
There are quite a few elements that contribute to the safety of a medical device including:
- Electrical and electromagnetic safety –You will need to demonstrate that the use of the device poses no electrical and electromagnetic risks to the environment, operators, end users and patients.
- Medical device sterilization –You will need to show that your products are sterile (i.e., free of viable microorganisms) in accordance with the required Sterility Assurance Level (SAL).
- Product labeling – Labeling needs to accurately reflect the indication for use of the device and needs to adhere to handling, shipping, and storage requirements. Incorrect labeling may result in incorrect use and adverse results.
We will work with you to ensure that your product complies with all relevant safety standards.
The word biocompatibility refers to the interaction between a medical device and the tissues and biological systems of the patient treated with the device. Evaluating biocompatibility contributes directly to device safety. There are different ways to determine if a device is biocompatible. These can be investigated by using diverse methods such as analytical chemistry, in vitro tests, and animal models. Li-Med has partnered with Eurofins to offer its Israeli clients with testing that ensures biocompatibility compliance.
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