The medical device industry is constantly adapting to emerging technologies, methodologies and changes in the regulatory landscape. Aptiv Solutions remains at the forefront of this challenging sector by offering strategic consulting and a full range of CRO services to address the contemporary medical device landscape.
Increased Regulatory Focus
Certain aspects of medical device regulation have seen greater emphasis in the past several years. Aptiv Solutions has tracked the trends which are so important to those developing new medical devices and is capable of providing top tier assistance in handling the following areas:
Human Factors – Not only must modern medical device manufacturers be capable of providing evidence that their product is effective, but with increasing regularity the FDA and other regulatory agencies are demanding similar evidence-based testing to prove that patients and practitioners can safely use the medical device exactly as intended. Human factors, ergonomics and usability testing and design are a necessary aspect of medical device development – one which Aptiv Solutions is intimately familiar with.
BIMO (audit/training and inspection) – We can provide expert advice and planning to help medical device manufacturers and developers prepare for site inspections and audits from the FDA’s Division of Bioresearch Monitoring. Aptiv Solutions also offers full ISO 14155 training for clinical research and trial sites relating to medical device development.
GMP Issues – Aptiv Solutions can help any medical device manufacturer meet the demands of the FDA’s Good Manufacturing Practices quality system, including the development and implementation of a complete quality control and records structure. We can also rapidly step in and assist medical device manufacturers to formulate a response to Form FDA 483 to help avoid the issuance of a Warning Letter.
Emerging Medical Device Sectors
Technological advances in the treatment and especially the diagnosis of disease have led to the emergence of several new and important medical device categories. Aptiv Solutions has kept pace with these next-generation medical device sectors and can offer in-depth regulatory and clinical advice for the following:
Personalized Medicine – As public, professional and federal interest in personalized medicine grows, medical device companies will be forced to seek out expert counsel in order to navigate the growing regulatory structure that is being assembled around this sector of the industry. Aptiv Solutions can provide cutting edge, firsthand experience for new and expanding medical device developers targeting the field of personalized medicine and companion diagnostics.
LDT (laboratory developed tests) – Medical device companies are increasingly involved in the manufacture and sale of equipment designed to meet the need of both consumer and practitioner laboratory developed test needs. As genetic testing and the use of IVDMIA tests, for example, becomes more prevalent throughout the medical industry, medical equipment manufacturers can benefit significantly from our extensive knowledge of the still-forming regulatory environment addressing these technologies.