Our philosophy

 

Factory’s philosophy emphasizes on client involvement and reaching a standard of quality through dedication and a structured work ethic. The expertise and experience of our qualified professionals contributes to establishing the safety and performance or efficiency of your medical devices, device/drug combinations, or biological/cell based products before and after entering the market.

Commencement speed, testing, and the timely delivery of results in every clinical trial guarantees you the optimal result in research solutions. The key to success in conducting a clinical trial is to have all the necessary information needed at hand. Factory helps you obtain this information.

Mission

At Factory we focus on success and advancement in the field of medical device trials and testing. Our methods are centered around the testing of the conformity of product properties with predetermined safety requirements. The release of products onto markets that are both completely functional and technologically advanced is one of our most vigorously stressed responsibilities.

We offer guidance to manufacturers of medical devices and provide advice and facilities for pre-clinical and clinical research with an overall aim, in these respective fields, to become a market leader.

Vision

Our foremost goal is to improve the safety and efficiency of medical devices, IVDs, medical device/drug combinations, biologicals and cell-based products around the globe.

Back in 1998, clinical trials for registration were required for pharmaceuticals. However, there was no European law requiring clinical trials for medical devices. We had the expertise, thus our goal has always been to become a global, market leading CRO in medical devices.

Expertise

Helmed by medical professionals, with extensive therapeutic and regulatory experience, Factory is built upon high levels of expertise. Our team is specialized in medical devices since our initial foundation, thus making Factory the most experienced and knowledgeable CRO in the field.

Our success is based upon providing our valued clients a combination of medical and technical expertise within our tightly-controlled clinical studies. We dedicate ourselves fully to your medical device approval and placement into the market, with the applications of cost effectiveness and efficiency always in mind. We provide unmatched expertise from initial product trials to clinically approved product results, and because of this, without a doubt, are viewed by our clients and partners as a trusted and valued adviser in clinical trials and development.

Global reach

Of all reputable CROs listed in the Applied Clinical Trials, Factory is the only CRO outside the US specialized in medical devices. We have already a very broad operation field, consisting of local representatives with academic background or years of experience.

We are based in the USA, Europe and the Caribbean, and have branches spread out all over the globe, including many parts of South America, Australia and Canada. We ensure that our global teams are proactive and organized, always aiming for maximum service and efficiency to our clients and partners all over the globe.

Focus

To obtain the best possible solutions and results, there must be clear focus. Through high levels of experience and focused expertise, Factory ensures the speediest and most efficient trials for product approval. From initial development strategies to regulatory approval, we offer the most concentrated and effective team effort from start to finish.


Values

Appreciating the importance of quality, in turn, will produce quality that is appreciated

Dedication

Factory is renown for it’s dedication to it’s clientele base. Hard work, communication and responsibility are palpable traits in our highly customer focused atmosphere. Because of the importance Factory places on teamwork and spirit, our employees are extremely motivated and driven to achieve maximum potential. Not only is there a highly focused and professional work ethic, but there is also an element of family and fun, which is essential in developing a team that can continuously work and succeed together. A positive work atmosphere directly contributes to better work ethic. Our executives and staff work side by side with surgeons across Europe and the USA, to assure you the right contacts, the best local knowledge, and the fastest clinical start-up. The dedication of Factory, and its professional team, is inherent to the quality standards which we strive to achieve in the world of medical device testing.

Quality

The world of medical device testing requires certain codes of conduct that must always be adhered to. It is our strong belief that procedures and processes must be drawn out and accomplished with a backbone of clear moral fiber. We have in house ISO-9001/ISO-13485 certified Standard Operating Procedures that comply with ISO-14155 (EN450) regulations. In fact, Factory was in 1996 the first CRO in the world to obtain ISO-9001 certification for its medical device focused Standard Operating Procedures.

Speed

To increase the rate of productivity, our professionals at Factory use a combination of speed and efficiency. With an extensive network of clinical, surgical and regulatory professionals at our disposal, device approval can normally be received in Europe within the time period of 8 to 10 weeks. It goes without saying, of course, that quality of work is always Factory’s first concern. Thanks, in no small part, to our utilization of IT/Technology, we are able to achieve maximum efficiency and timely service without compromising quality. While maintaining full, but flexible, service our flat organizational structure makes for short and efficient lines of communication and strong work teams. We are focused on being proactive and responsive, delivering the top results for your clinical trial.

Integrity

Factory has developed a culture of integrity and respect. Above all, we hold ourselves accountable for our actions and follow a strict code of ethics. Our focus lies in finding direct solutions and achieving top results, while actively engaging our clients and partners in the entire device trial process. Factory believes in keeping promises and commitments, and are ourselves personally committed to the success of your medical devices. Your success is our success.