Who We Serve: Clinical Area
Implantable Devices
An implanted device cannot be inspected once it is in a patient, so the quality system has to carry that weight: material and process records that trace to a single unit, and postmarket data that can reach back to them. We help implant manufacturers test that chain end to end.
Standards and Regulations to Know
- ISO 10993-1Biological Evaluation Within a Risk Management Process
- ISO 14971Risk Management for Medical Devices
- ISO 11607Packaging for Terminally Sterilized Medical Devices
- 21 CFR Part 820 (QMSR)Quality Management System Regulation
- 21 CFR Part 830Unique Device Identification
- 21 CFR Part 803Medical Device Reporting
- EU MDR (Regulation (EU) 2017/745)European Union Medical Device Regulation
- ISO 13485Quality Management Systems for Medical Devices
Typical Regulatory Exposure
Implants are typically higher-risk devices, often Class II or III in the US and Class IIb or III under the EU MDR, so they tend to bring design controls, clinical evidence and close postmarket scrutiny. Biological evaluation under the ISO 10993 series has to account for long-term contact, degradation products and any change in materials or processing that could alter the patient-contacting surface.
Traceability is the defining requirement. The QMSR's FDA-specific record requirements include UDI, and some implants are subject to FDA device tracking so the manufacturer can locate devices down to the patient. Under the EU MDR, most implantable devices also need an implant card and information for the patient.
Postmarket evidence matters more for implants because problems can surface years after surgery. Complaint handling, explant analysis, medical device reporting and post-market surveillance all need to feed back into the risk file, and an auditor following one explant through the system will see quickly whether they do.
Where Audits Find Gaps
- 01
Unit Traceability Breaks at a Subcontractor
Lot or serial records link finished devices to raw material certificates, but the chain breaks at an outsourced step such as coating, cleaning or sterilization.
- 02
Biological Evaluation Not Revisited After Changes
A supplier, cleaning agent or process parameter changed and the biological evaluation was not reassessed, or the rationale for not retesting was never recorded.
- 03
Returned Explants Not Analyzed
Explanted devices come back from surgeons and sit unexamined, or are examined with no link to the complaint record, the reportability decision or the risk file.
- 04
Tracking Records Incomplete
For devices under tracking requirements, distribution records stop at the distributor or hospital, and patient-level information is missing or out of date.
- 05
Implant Card Content Unverified
For EU markets, the implant card and patient information exist, but nobody has checked them against the current device, its UDI and its known risks.
Relevant Standards and Regulations
- ISO 10993-1Biological Evaluation Within a Risk Management Process
- ISO 14971Risk Management for Medical Devices
- ISO 11607Packaging for Terminally Sterilized Medical Devices
- 21 CFR Part 820 (QMSR)Quality Management System Regulation
- 21 CFR Part 830Unique Device Identification
- 21 CFR Part 803Medical Device Reporting
- EU MDR (Regulation (EU) 2017/745)European Union Medical Device Regulation
- ISO 13485Quality Management Systems for Medical Devices
Relevant Services
AI-Assisted QMS Gap Assessment
An AI-assisted first pass over the QMS documents you already have, with every result reviewed by an advisor.
FDA Inspection Readiness (CP 7382.850)
FDA device inspection preparation built around Compliance Program 7382.850 and its risk-based approach.
CAPA System Remediation
Fixing a CAPA system auditors keep citing: the procedure, the records, root cause, effectiveness and backlog.
EU MDR and IVDR Readiness
Prepare your QMS and technical documentation for notified body audits under the EU MDR or IVDR.
Supplier Audits and Supplier Controls
Risk-based supplier selection, quality agreements, monitoring and supplier audits that hold up under QMSR.
Audits and Inspections You May Face
FDA Baseline Surveillance Inspection
FDA's comprehensive surveillance inspection of your quality system under Compliance Program 7382.850.
EU Notified Body Audit (Including Unannounced Audits)
Conformity assessment, surveillance and unannounced audits by an EU notified body under the MDR or IVDR.
FDA PMA Pre-Approval Inspection
An FDA inspection tied to a PMA application that checks your quality system and its match to the submission.
Questions
Which implants are subject to FDA device tracking?
Tracking applies to devices FDA has ordered to be tracked, so it is device-specific. Tracking is one of the areas investigators consider under Compliance Program 7382.850, so confirm with your regulatory team whether an order covers your device before an inspection does it for you.
What does an auditor usually trace on an implant?
Often a single unit, from a complaint or explant back through distribution, production records, sterilization, cleaning and raw material certificates. Any break in that chain tends to shape the rest of the audit.
Do we need to repeat biocompatibility testing after every change?
Not always. ISO 10993-1 frames biological evaluation as a risk-based process, so a change can be justified without new testing when the rationale holds. The gap auditors find is usually a missing rationale, not a missing test.
Implantable Devices
Get an Advisor's View of Your Quality System
Tell us about your devices and the audit or inspection ahead, and an advisor will scope an assessment for your kind of product. Please don't send confidential documents yet: secure upload is set up after onboarding.
