Our team of engineers and development professionals has extensive regulated industry experience working on design and development projects. We have provided program and project management services developing new products with complex embedded systems for the last two decades. Specific medical device design, manufacturing and commercialization projects our has contributed to include, but are not limited to: mobile apps, cardiac monitoring / imaging systems and disposables, pulse oximetry sensors and systems, orthopedics such as knee, hip, and spinal implants (pedicle screws, fusion devices, artificial discs, stabilization, anterior reduction, etc.), electrosurgical generators and ablation probes, robotic surgical and tactile guidance systems, spinal stiffness and fusion management systems, endoscopic instrumentation, ENT disposables such as endotracheal and tracheostomy tubes, breathing circuits, and nebulizers as well as general surgical instrumentation. Our team is quite comfortable and competent working in the regulated environment especially in relation to FDA requirements including 21 CFR Part 820.30 as well as ISO 13485:2003, EN ISO 13485:2012, and ISO 13485:2016.
The software development group is able to provide a full range of services including software planning, requirements generation, software coding and configuration management, unit, system and integration testing for embedded and stand-alone software products as well as mobile applications. We are well-versed in the software development life cycle and associated documentation requirements for both FDA and IEC 62304 compliance.
Design Engineering and Electrical Safety
Medical device development can be a complex process. The team is available to provide electrical engineering, mechanical engineering, prototyping, and CAD (3D and 2D) drawing. Our experienced engineers are very familiar with the regulatory requirements for electrical safety according to IEC 60601-1 (3rd edition) and related documentation including PEMS and RoHS.
Risk management is part of our lives on many levels and is now an integrated element of regulatory compliance in most global markets. We can assist your firm in preparing risk management programs, procedures, and plans as well as conducting risk analysis and post-market surveillance (an often-overlooked aspect of risk management) for both hardware and software-based products according to ISO 14971, IEC 62304, and the IEC 60601-1 series of standards.
Human Factors Engineering (Usability)
Considering human factors related to medical device usage is a critical aspect of product development. Examples of our expertise in this area include systems engineering, risk management & usability procedure development at multiple medical device companies, author(s) of design verification and validation plans, protocols & reports, author(s) of formative testing, summative testing & HF/UE reports, successful track record in FDA and CE technical file submissions for home healthcare, mobile devices, and clinical use devices. Applicable standards include: ANSI/AAMI HE75, IEC 62366-1, IEC 60601-1, IEC 60601-1-6, IEC 60601-1-11, and ISO 14971.