At Silcotech North America Inc., quality is central to the trust our customers place in us. We continue to strengthen that foundation through our quality management systems, independent certification, and preparation for the regulatory requirements that matter to our customers.

In Q3 2026, Silcotech transitioned its certification body from NSF to UL Solutions, which now holds our current ISO 9001 and ISO 13485 certifications. ISO 9001 supports consistent processes, customer satisfaction, and continuous improvement, while ISO 13485 addresses quality management requirements specific to the medical device industry. These standards provide a framework for maintaining a disciplined approach to quality and meeting applicable customer and regulatory requirements.

Building on this foundation, we are working toward certification under the Medical Device Single Audit Program (MDSAP), with certification expected by the end of 2026. MDSAP allows a recognized auditing organization to conduct a single audit that addresses the relevant requirements of multiple participating regulatory authorities. For Silcotech, pursuing this certification is an important step in strengthening our quality assurance program and supporting customers operating across international medical device markets.

Looking ahead, we are targeting completion of our European Union Medical Device Regulation (EU MDR) implementation by Q2 2027. The EU MDR establishes a regulatory framework focused on medical device safety, transparency, and traceability. Our implementation work is intended to align relevant processes with applicable requirements and strengthen our readiness to support customers with European medical device programs.

For our customers, these initiatives reflect our continued focus on dependable manufacturing, clear quality expectations, and long-term partnerships. As medical device projects progress and requirements develop, we want our quality systems to provide a strong foundation for the work we undertake together.

Thank you to our Quality Assurance team and colleagues across Silcotech for the attention to detail, collaboration, and commitment to continuous improvement that drive this work forward.

From initial concept to a market-ready product, Silcotech’s experts provide the guidance and capabilities needed at every stage, from product development and tooling to production and post-molding operations. We’ll be your trusted partner throughout your entire manufacturing journey.

𝗣𝗿𝗼𝗱𝘂𝗰𝘁 𝗗𝗲𝘃𝗲𝗹𝗼𝗽𝗺𝗲𝗻𝘁 𝗮𝗻𝗱 𝗗𝗲𝘀𝗶𝗴𝗻 𝗳𝗼𝗿 𝗠𝗮𝗻𝘂𝗳𝗮𝗰𝘁𝘂𝗿𝗶𝗻𝗴
Silcotech supports product development through design-for-manufacturing analysis and mold-filling simulations, enabling faster design iterations before significant investments are made in tooling and production.

𝗖𝗹𝗮𝘀𝘀 𝟭𝟬𝟱 𝗧𝗼𝗼𝗹𝗶𝗻𝗴
Our quick-iteration prototype tooling produces cast or injection-molded samples for initial form, fit and function testing. This allows customers to refine their products and validate production processes before advancing to production tooling.

𝗖𝗹𝗮𝘀𝘀 𝟭𝟬𝟯 𝗧𝗼𝗼𝗹𝗶𝗻𝗴
Bridge tooling provides a cost-effective way to manufacture high-quality parts in low-to-medium volumes. These pre-hardened steel molds can also undergo full validation, helping customers meet quality requirements while preparing for mass production.

𝗖𝗹𝗮𝘀𝘀 𝟭𝟬𝟭 𝗧𝗼𝗼𝗹𝗶𝗻𝗴
For high-volume production, Silcotech designs fully hardened, multi-cavity tooling for long service life and fast cycle times. Each system can incorporate customized automation and high-speed robotic part removal.

𝗣𝗿𝗼𝗰𝗲𝘀𝘀 𝗮𝗻𝗱 𝗧𝗼𝗼𝗹𝗶𝗻𝗴 𝗤𝘂𝗮𝗹𝗶𝗳𝗶𝗰𝗮𝘁𝗶𝗼𝗻𝘀 𝗮𝗻𝗱 𝗩𝗮𝗹𝗶𝗱𝗮𝘁𝗶𝗼𝗻
Silcotech employs IQ, OQ, PQ and PPAP protocols to qualify equipment, tooling and production processes. These reports establish reliable process windows and demonstrate adherence to applicable quality standards.

𝗣𝗼𝘀𝘁-𝗠𝗼𝗹𝗱𝗶𝗻𝗴 𝗢𝗽𝗲𝗿𝗮𝘁𝗶𝗼𝗻𝘀
Our value-added capabilities include in-mold assembly, post-molding assembly, coating, decorating, post-curing and packaging—all customized to the specific requirements of each project.

Tell us about your project and discover how Silcotech can support it from initial concept to high-volume production, request a quote today:

https://silcotech.com/request-a-quote/

Silcotech has implemented GoAudits, a digital auditing platform that strengthens how we conduct and manage our monthly Good Manufacturing Practices (GMP) audits. These audits help us verify compliance with our GMP procedures, ISO Class 8 cleanroom requirements, and facility-wide 5S and safety standards.

By replacing our previous paper-based process, GoAudits allows us to perform audits more efficiently and consistently. Auditors can capture real-time photographic and video evidence, assign corrective actions to the appropriate personnel, and monitor follow-up activities through completion. The platform also helps us analyze audit data, compare results, and identify performance trends over time.

Our latest audit demonstrated strong compliance throughout the facility and highlighted continued improvement in our GMP, cleanroom, housekeeping, and safety practices. These insights will support Silcotech’s ongoing commitment to quality, accountability, and continuous improvement.

During their Annual Members Meeting on June 17th, 2026, BrightStart Caledon Family Centre recognized Silcotech North America Inc. for their financial support over the past 2 decades. Silcotech’s donations and sponsorship now exceed $10,000, a giving milestone that earns them the position of Founder on BrightStart Caledon’s donor wall.

At the meeting, Silcotech’s Vice-President, Isolde Boettger spoke briefly, sharing how happy they are to support BrightStart Caledon’s mission – to provide a safe and engaging space for Caledon families and children to connect, learn and grow. Isolde has long been a strong supporter of the Caledon community, working hard over the years to support Caledon nonprofits and social service organizations whenever she could.

Silcotech North America was proud to once again support Caledon Community Services’ Velocity Ride. This year was especially important as Silcotech took on the challenge of becoming the Grand Tour Sponsor, in turn helping to make the 2026 event its most successful yet.

Held on June 20 at Caledon East Park, Velocity 2026 brought together hundreds of cyclists, volunteers, sponsors and community supporters. The event raised an outstanding $65,320.70, more than $10,000 above its original $55,000 fundraising goal, to help replace aging CCS vehicles that provide affordable and accessible transportation for seniors in the Caledon community.

Silcotech employees enthusiastically embraced the cause, earning recognition as the Largest Team of Velocity 2026. The accompanying photo captures representatives from Caledon Community Services presenting Silcotech with several commemorative certificates and awards in appreciation of the company’s sponsorship, participation and continued commitment to the event.

Transportation services supported by Velocity help local seniors attend medical appointments, purchase groceries and remain active and independent. With CCS anticipating the need to replace as many as seven aging buses by the end of 2027, the success of this year’s ride demonstrates how strongly local businesses, residents and volunteers believe in supporting seniors and caring for one another.

Silcotech extends its sincere thanks to the members of Team Silcotech, the organizers at Caledon Community Services, the 142 volunteers, fellow sponsors, donors and everyone who participated in this year’s ride. We are honoured to contribute to an initiative that delivers a meaningful and lasting impact throughout our community.

We’re proud to share that Silcotech North America recently received a supplier recognition award from Neotech Products for our contribution to the Neotech Bridge®.

The Neotech Bridge® is an innovative breastfeeding assistance device designed to help infants receive supplemental nutrition while remaining latched at the breast or chest. It is so gratifying knowing that our work contributes to such an incredible product that supports families, caregivers, and healthcare professionals. It makes this recognition especially meaningful.

This award reflects the strength of our partnership with Neotech and the dedication of the Silcotech team who helped in bringing a medical product from concept to production. This entire project required close collaboration, problem-solving, and a commitment to quality every step of the way.

We would like to thank the team at Neotech and acknowledge the dedication of the hard-working employees of Silcotech whose engineering, manufacturing, quality, and project management efforts helped make this product a success.

At Silcotech, we’re fortunate to work on products that have a real impact on people’s lives. The Neotech Bridge® is a great example of how innovation, thoughtful design, and strong manufacturing partnerships can come together to create meaningful solutions.

Thank you again to Neotech for this recognition and for the opportunity to be part of this journey. We look forward to continuing our partnership in the years ahead.

Silcotech was proud to sponsor Wines of the World 2026, hosted by the Rotary International Club of Caledon on June 6th at Caledon Equestrian Park. The weather couldn’t have been better for such an incredible outdoor event! It was a wonderful evening, President Michael Maloney and Vice-President Isolde Boettger were at the event pouring wine for the attendees at Silcotech’s sponsored table. We were pleased to be there representing Silcotech, sharing more about what we do, and supporting an event that helps fund meaningful Rotary initiatives in our community and beyond.

At Silcotech, community involvement has always been an important part of who we are. Events like Wines of the World show the impact that can be made when local businesses, volunteers, sponsors, and attendees come together for a great cause. Thank you to the Rotary Club of Caledon, the volunteers, fellow sponsors, and everyone who attended and helped make the evening such a success. We look forward to next year’s event (hopefully it’ll be the best one yet!). Those interested in supporting the Rotary Club of Caledon can learn more about the club, its community projects, and ways to get involved or donate by visiting the Rotary Club of Caledon website www.caledonrotary.com or contacting the club directly at rcpalgrave@gmail.com.