iRegained

As an award-winning ISO 13485:2016 and ISO 9001:2015 design and engineering firm established in 1999, Cortex exists to create beautiful and life-changing experiences that substantially improve human quality of life. We use human-centred design principles and engineering discipline within a regulatory framework to deliver solutions to our customers that significantly amplify stakeholder value. Clients engage us when they need a flexible, responsive team to support and / or augment their internal resources. While we have the formality of our QMS and internal processes to deliver for some of the biggest clients in the world, our Design for Commercialization™ methodology is creative and agile in nature. As a result, our team has the ability to meet a client where and how they want to engage.

Engineering CPR is a reliable solution for all your Medical Device Product Development and Contract Manufacturing needs. With a team of senior engineers and skilled staff, we we have the experience to protect your schedule. Our leadership team has a combined experience of over 90 years in Product Development, Manufacturing, and Industrial Testing. If you require assistance in meeting your Product Development & Commercialization targets, we are here to support and guide you.

Inertia offers fully integrated end-to-end physical product development and manufacturing services for hardware start-ups and SME’s. With two decades of experience, Inertia has grown into a multifaceted organization that excels in concept ideation, prototyping and validation, detailed design and engineering, design for manufacturing, and managed contract manufacturing services.  What sets Inertia apart is their ability to offer a true, fully integrated product development and manufacturing experience under one roof, ensuring a seamless, rapid, and capital efficient journey from conception to product delivery.

Ironstone Product Development (IPD) has proudly joined Avania, a leading, global full-service contract research organization offering targeted, actionable strategies for Medical Devices and Diagnostics. As Canada’s only full-service medical device consultancy, the combined organization offers regulatory affairs consulting, clinical trial design, and turnkey product development. Our team of engineers, clinicians, and regulatory experts have developed life-saving devices, authored many ISO 13485 compliant quality management systems, and successfully secured FDA, Health Canada, CE Mark (Europe), TGA (Australia), SFDA (China), and KFDA (Korea) approval for Class I, II, and III devices in a variety of application areas including neurology, critical care, imaging, women’s health, and anesthesia.

Linamar’s Innovation Hub (iHub) is discovering solutions to global healthcare problems by partnering with aspiring entrepreneurial start-ups/scale-up companies to create a new future with products that are world leaders in technology, innovation and manufacturing.

With an aging global population, new innovations are needed to allow at home care, rapid diagnostics/imaging and less intrusive surgical practises. With Linamar’s Innovation Hub achieving ISO13485 certification we’re seeking late-stage medical device companies;

• Diagnostic Devices
• Assistive Devices
• Rehabilitation Devices
• Treatment Devices
• Monitoring Devices
• Imaging Devices

Megalab Group Inc., Canada’s fastest-growing consulting lab for certification & approval, is unique in North America offering testing services (UL/CSA/ETL/CE)  from one “State of the Art” facility. Megalab offers ISO 17025 (A2LA) Accredited, EMC, Product Safety, Mechanical & Laboratory Testing Services. We operate from a state-of-the-art engineering facility spanning over 40,000 square feet. Our facility is equipped to handle a wide range of testing requirements, making it a convenient one-stop-shop for all your testing needs. Megalab Group Inc. and its team are committed to meet and exceed our customers’ expectations as an industry leader in environmental and related regulatory testing services, through constant business improvement while upholding the highest integrity and quality in stand.

Microart is a custom electronic manufacturing and design services company providing PCB Layout, Material Procurement, PCB Assembly, Testing & Test Fixture Development and Box Build. Specializing in high mix, high complexity assembly solutions we utilize both SMT automation equipment and manual assembly techniques to custom tailor your product’s assembly profile for maximum proficiency and expediency.

Synapse Life Science Consortium is the formal regional cluster organization for the life sciences ecosystem in the greater Hamilton region. An initiative of Innovation Factory and its community partners, Synapse supports efforts and projects that magnify the impact of collective action across the cluster ecosystem and accelerate the commercialization of life science innovation. Synapse strives to support all organizations that make up the Hamilton life science cluster, celebrating the strengths and successes of industry leaders and new start-ups, as well as promoting the region as an attractive place to live, work and invest.

Founded in 2016, the Consortium brings together leaders from across the region, including private- and public-sector organizations who saw opportunity for greater collaboration and coordination across the cluster. Synapse Consortium partners represent the bulk of life science research and economic activity in Hamilton.