Stop Losing Bids to ISO-Certified Competitors

Your competitor just won the $500K contract you should have gotten. The technical evaluation was comparable. Your pricing was competitive. But the procurement scorecard gave them 15 points for ISO 13485 certification - and you got zero. This is the third major bid you've lost this year to certified competitors. The pattern is clear: without ISO 13485 certification, you can't compete for the opportunities your capabilities deserve.

Many ISO consultants will hand you generic templates, create documentation that doesn't reflect how you actually work, and leave you with a quality management system nobody follows. We don't work that way. In over 200 ISO certification projects across quality, environmental, safety, information security, and energy management standards, including integrated management systems addressing multiple standards, we've never had a client receive a Major finding or fail their certification audit. Not once. We achieve first-attempt certification in 3-6 months by building quality management systems tailored to your actual operations - not copying templates that create bureaucratic nightmares.

What is ISO 13485 Certification?

ISO 13485 is the internationally recognized standard for quality management systems specific to the medical devices industry. It specifies requirements for organizations involved in the design, production, installation, and servicing of medical devices and related services. Whether you're a device manufacturer, contract manufacturer, component supplier, or sterilization provider, ISO 13485 demonstrates regulatory compliance, facilitates market access, and ensures patient safety through systematic quality controls.

Why medical device companies pursue ISO 13485:

• Required for CE marking and selling medical devices in European and international markets
• Aligns with FDA QSR (21 CFR Part 820) and supports successful FDA inspections
• Mandatory for medical device supply chain qualification and OEM supplier approval
• Demonstrates design controls, risk management, and validation required for device safety

ISO 13485 certification enables international market access and revenue growth, ensures FDA and global regulatory compliance, qualifies your company as a trusted medical device supplier, and provides a systematic framework for device safety and quality assurance.