As a manufacturer of medical devices, you bear great responsibility. The product has to guarantee greatest possible benefits, while meeting high legal requirements. Our experts give you the assurance you need that you meet both these requirements. As an internationally recognized "notified body" and present in over 60 countries, we can also help you get quick and easy access to markets worldwide.
Design, prototyping, and product development
Biomedical device product manufacturing is a long process requiring robust SOPs and guidelines for production. These days, with the aid of CAD or modelling platforms, the work is now much faster, and this can act also as a tool for strategic design generation as well as a marketing tool.
Failure to meet cost targets will lead to substantial losses for an organisation. In addition, with global competition, the R&D of new biomedical devices is not just a necessity, it is an imperative for biomedical device manufacturing companies. The realisation of a new design can be very costly, especially with the shorter product life cycle. As technology advances, there is typically a level of quality, safety and reliability that increases exponentially with time.
For example, initial models of the artificial cardiac pacemaker were external support devices that transmits pulses of electricity to the heart muscles via electrode leads on the chest. The electrodes contact the heart directly through the chest, allowing stimulation pulses to pass through the body. Recipients of this typically suffered infection at the entrance of the electrodes, which led to the subsequent trial of the first internal pacemaker, with electrodes attached to the myocardium by thoracotomy. Future developments led to the isotope-power source that would last for the lifespan of the patient.
Standardization and regulatory concerns
The ISO standards for medical devices are covered by ICS 11.100.20 and 11.040.01 The quality and risk management regarding the topic for regulatory purposes is convened by ISO 13485 and ISO 14971. ISO 13485:2003 is applicable to all providers and manufacturers of medical devices, components, contract services and distributors of medical devices. The standard is the basis for regulatory compliance in local markets, and most export markets. Additionally, ISO 9001:2008 sets precedence because it signifies that a company engages in the creation of new products. It requires that the development of manufactured products have an approval process and a set of rigorous quality standards and development records before the product is distributed. Further standards are IEC 60601-1, for electrical devices (mains-powered as well as battery powered) and IEC 62304 for medical software. The US FDA also published a series of guidances for industry regarding this topic against 21 CFR 820 Subchapter H-Medical Devices. To meet the demands of these industry regulation standards, a growing number of medical device distributors are putting the complaint management process at the forefront of their quality management practices. This approach further mitigates risks and increases visibility of quality issues.