SYLKE® has achieved ISO 13485:2016 certification and completed an audit under the Medical Device Single Audit Program (MDSAP). These milestones confirm that our quality management system (QMS) has been assessed against applicable standards and regulatory requirements. They are not product endorsements, regulatory approvals, or clearances, and do not address the safety or effectiveness of any specific product.
Why this matters:
Medical devices are held to high, global standards. ISO 13485:2016 is the international standard for medical device quality management systems. MDSAP is a single, rigorous audit program accepted by participating regulatory authorities. Together, they help ensure we design, manufacture, and distribute our products under a consistently controlled, traceable, and risk-managed system.
What ISO 13485:2016 certification means:
ISO 13485:2016 certification confirms our QMS meets stringent, device-specific requirements, including:
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Documented risk management across the product lifecycle.
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Supplier qualification and ongoing oversight.
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Process validation and change control.
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Vigilance, complaint handling, and corrective/preventive actions (CAPA).
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Training, competence, and management review.
What the MDSAP audit adds:
MDSAP assesses our QMS against the requirements of participating regulatory authorities through one audit. Completion indicates alignment with a harmonized set of expectations and may support market access where accepted; it does not grant marketing authorization.
What this means for our customers, partners, and patients:
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Reliability you can audit: Clear traceability from materials to finished product.
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Consistent quality: Validated, monitored processes with defined acceptance criteria.
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Responsive improvement: Formal systems for feedback, complaints, CAPA, and post-market surveillance.
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Supplier control: Qualification, monitoring, and re-evaluation of critical suppliers.
A note from our team:
“These milestones reflect disciplined systems building. Our focus now is the same as ever: maintaining and improving a QMS that earns trust—every day, in every lot.”
— The SYLKE® Quality & Regulatory Team
What’s next:
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Ongoing surveillance/audit cycles per ISO 13485 and MDSAP requirements.
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Continued investments in risk management, human factors, and post-market monitoring.
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Transparent communication with customers, distributors, and regulators.
Need documentation?
If you’re a distributor, clinician, or partner who needs our current certificates or quality policy, contact quality@sylke.com. We’re happy to provide the latest documents and answer any questions.
Supporting new market access:
Participating regulators that accept MDSAP audit reports include the U.S. FDA, Health Canada, Australia’s TGA, Japan’s MHLW/PMDA, and Brazil’s ANVISA.*
*Acceptance of an MDSAP audit report does not grant product authorization. Availability and requirements vary by country—follow local regulations.
Compliance note: Always follow the current SYLKE® Instructions for Use (IFU) for indications, contraindications, warnings, and instructions for use. References to certification and auditing relate solely to SYLKE®’s quality management system (QMS). They do not imply regulatory approval or clearance, nor do they guarantee product performance or speak to the safety or effectiveness of any product.
