Medical Devices · ISO 13485
ISO 13485 Consulting for Medical Device Manufacturers
The short answer
ISO 13485 defines a quality management system for organizations involved in the medical device lifecycle. We help manufacturers implement it as an operating system — including organizations moving from a Part 820-shaped system, and organizations building their first QMS ahead of production.
Why this matters
- The standard is process-based; systems built as a folder of procedures per clause tend to pass certification and fail in practice.
- Documented information requirements are specific, and missing records are the most common nonconformity type at audit.
- For US manufacturers, ISO 13485 work now sits directly alongside FDA quality system expectations under QMSR.
Applicable regulations and standards
- ISO 13485:2016
- Requirements for a medical device quality management system.
- ISO 14971
- Application of risk management, referenced throughout ISO 13485.
- 21 CFR Part 820 (QMSR)
- FDA incorporation of ISO 13485 for US manufacturers.
- IEC 62304
- Software lifecycle processes where the device includes software.
What our consultants actually do
- Design a process-based QMS structure rather than a clause-by-clause procedure set
- Run gap assessments for organizations transitioning from Part 820 or from no formal QMS
- Build design control, purchasing, production and post-market processes with the records the standard requires
- Establish the internal audit program, audit schedule and auditor qualification
- Prepare the organization for certification or surveillance audit, including management review evidence
- Support nonconformity response and corrective action following an audit
Across the product lifecycle
01 / DEVELOP
Design and development planning, inputs, outputs, review and verification records.
02 / SCALE
Infrastructure, work environment and competence requirements defined.
03 / TRANSFER
Design transfer to production with validated processes.
04 / VALIDATE
Process validation and software validation records per the standard.
05 / MANUFACTURE
Product realization, traceability and identification controls.
06 / MAINTAIN
Feedback, complaint handling, internal audit and management review.
Problems we are usually called about
- Procedures written to mirror clause numbering rather than how work flows
- Design history file assembled retrospectively before an audit
- Supplier evaluation records that document selection but not ongoing monitoring
- Software validation for QMS tools never performed
- Management review held without the required inputs documented
Typical deliverables
- QMS structure and process map
- Gap assessment against ISO 13485:2016 with remediation plan
- Core procedures and record templates
- Internal audit program, schedule and checklists
- Certification readiness review report
Frequently asked
- How long does ISO 13485 implementation take?
- For a small manufacturer building from scratch, typically six to twelve months to a certifiable system with real operating history. Organizations converting an existing Part 820 system usually move faster.
- Do you perform the certification audit?
- No. Certification must come from an accredited certification body. We prepare the organization, run internal audits and support the response to any nonconformities.
- Can one quality system satisfy ISO 13485 and FDA requirements?
- Yes, and it should. Maintaining two parallel systems is the main source of contradiction we find during assessments.
References
More for medical devices
QMSR, ISO 13485 and device manufacturing quality support.
- QMSR TransitionThe Quality Management System Regulation incorporates ISO 13485 into FDA's device quality system requirements.
- Process ValidationDevice manufacturers must validate any process whose results cannot be fully verified by subsequent inspection and test.
- CAPACAPA is the system FDA examines first in a device quality system, because it reveals whether the organization detects and fixes its own problems.
- Supplier QualityPurchasing controls make you responsible for the quality of what others make for you.
- 510(k) Quality SupportThis page is about the part of a 510(k) that lives inside your quality system: the design history file, process and sterilization validation, supplier controls and the manufacturing description.
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