Are Customers required to follow a Manufacturers Maintenance Schedule?

T

temujin

#1
Dear Cove,

Currently working in the service department of a major medical device manufacturer,(under both 13485 and FDA rules)I have a question related to required planned maintenance routines for this equipment.

My company has a set of planned maintenace routines for our equipment both with respect to how often and what should be checked on scheduled maintenance. This maintenance is done by representatived of my company, not by the hospitals themselves.

When customers buy our equipment, it belongs to them [the hospitals] right?

So my question is to what extend must the hospitals (customers, end users) comply with these procedures of planned maintenance? Can the manufacturer "force" the customer to set aside time for this? If the customer would skip a planned maintenance are they allowed to?

Our regulatory dept clearly says no, however, I am in doubt since the equipment really belongs to the customer right?

any thoughts?
regards
t.
 
Elsmar Forum Sponsor
I

isoalchemist

#2
Your are never Required to follow the Manufacturer's maintenance schedule. With that said all of the standards do require that you have a maintenance schedule in place.

By default most use the manufactures recommendations since they should know the systems best, but based on actual use (run hours rather than days/months etc.) that may change for each company.

The interesting part becomes if a unit fails and is "MDR reportable" and it is not maintained per the manufacturer's recommendations. That becomes an interesting legal discussion.
 

ScottK

Not out of the crisis
Staff member
Super Moderator
#3
As isoalchemist says you can't require them to follow your instruction and schedule, but you can make it a warranty issue saying that if they do not follow the maintenance instructions and schedule then the warranty will be voided and they could risk malfunction of the device, causing a regulatory issue.

The option then is: do they do the maintenance themselves or hire your company to do it? You can't force them to hire your company to do it, so you should provide instructions for the periodic maintenance (as part of the instructions for use) so you have done your part if they choose to take it upon themselves.

Your techincal sales people should be convincing the customers that they really should retain you to do maintenance to cause them less risk of a failure.
 
M

MIREGMGR

#4
I've never seen it done, but it'd be possible via the 510(k) process to document for market clearance that a durable device is only sufficiently safe and effective if it's maintained per a specified procedure and schedule by persons with specified training, and then label the device accordingly.

Of course, such a condition on durable-device clearance would not require the buyer to use you to provide that maintenance service, but obviously it'd be a step in that direction. It also wouldn't force users to conduct such maintenance, since FDA cannot mandate doctors' actions, but it'd be a step in that direction too.

I reckon such conditions could be imposed via the regulatory process in the EU and other regulated markets, too.

A possible downside would be that buyers might look at the labeling and decide they'll buy a competing product without such requirements instead. That downside is probably why one doesn't see such regulatorily imposed conditions in the marketplace.
 
Last edited by a moderator:
Thread starter Similar threads Forum Replies Date
J What is required to tell customers after Audit where nonconformances are found IATF 16949 - Automotive Quality Systems Standard 20
B Cybersecurity Maturity Model Certification for military customers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
P ISO 9001 certification with zero customers? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
M Customers Request AS9100 certification - Small Company (less than 20 employees) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
J Which OEM or customers are now requiring the new AIAG/VDA FMEA format? FMEA and Control Plans 2
M Scope of Combined ISO 9001 and IATF 16949 QMS - Non-automotive customers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
D Do non-IATF customers need to be included in audit scope? IATF 16949 - Automotive Quality Systems Standard 23
NDesouza When Customers Make Changes to Orders Contract Review Process 24
T Was Just told we could ONLY buy material for AS9100 customers if the DISTRIBUTION house is AS9100 / AS9120 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
D Customer and Company Specific Requirements for notification of Customers of a change in Management or Key Personnel Customer and Company Specific Requirements 3
S Returned product due to Customers fault, is it a Non-Conformance? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
Sidney Vianna Interesting Discussion ISO 9001 audits from the perspective of registrants' customers - an interesting paper Registrars and Notified Bodies 0
S How to collect complaint data from customers Customer Complaints 24
A CE Mark PPE Category III for our customers residing in the EU CE Marking (Conformité Européene) / CB Scheme 1
Ed Panek Requirement to track and trend positive feedback from customers ISO 13485:2016 - Medical Device Quality Management Systems 12
R Medical Device (IVD) - Selling RUO to Customers EU Medical Device Regulations 2
T Restricting scope of AS9100 certification to a couple of customers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
C What are rules to notify customers if IATF cert is put on hold? IATF 16949 - Automotive Quality Systems Standard 2
R Concessions - ISO 13485:2016 requires concession approval from customers Nonconformance and Corrective Action 2
G AIAG FMEA - Major customers of the FMEA process FMEA and Control Plans 3
C Record retention for defunct customers? ISO 13485:2016 - Medical Device Quality Management Systems 11
M Can a foreign manufacturer sell directly to US customers? Other US Medical Device Regulations 4
D AS9100D 7.3 Awareness of customers quality policies AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 18
A Special Procedures for Non Aerospace Customers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
R AS9100 FAI - First Article Inspection to a prior Customers PO AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
B TS16949 Section 8.2.2.3 Product Audit - Requirements for various Customers IATF 16949 - Automotive Quality Systems Standard 10
Crimpshrine13 IATF 16949 Audits to include Processes and Products from Non Subscribing Customers IATF 16949 - Automotive Quality Systems Standard 20
N Do you make exceptions to your process for customers? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
D TS16949 requirements for for Directed Buy Customers IATF 16949 - Automotive Quality Systems Standard 5
M Document Control Management - External documents flowed down from customers Document Control Systems, Procedures, Forms and Templates 2
K ISO 9001:2015 Section 8.5.3 - Property belonging to customers or external providers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
M Does AS9120 (aerospace first article inspection) apply to all customers AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
D Dual Lot Manufacturing requirements for Clinical Customers Manufacturing and Related Processes 3
A SIPOC (Suppliers Inputs Process Outputs Customers) examples wanted Quality Manager and Management Related Issues 1
J Potential Customers Asking for EIRs / 483s when evaluating a CRO for future work US Food and Drug Administration (FDA) 2
N Survey to Customers Regarding Our Complaint Response Time Customer Complaints 7
B Creation of CAD solid models using customers supplied drawings AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
S CS2 (Controlled Shipping Level) by GM - CB notified. What about other customers? IATF 16949 - Automotive Quality Systems Standard 1
E How do you monitor Medical Device Off-Label use by Customers & Medical Professionals EU Medical Device Regulations 5
C Notification to Customers regarding Major Audit Finding IATF 16949 - Automotive Quality Systems Standard 25
C Clause 7.2 with no customers (yet) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
T IMDS - MDS request for parts supplied to multiple customers RoHS, REACH, ELV, IMDS and Restricted Substances 15
L PPAP Approval Woes - Getting signed PSW's back from Customers Supplier Quality Assurance and other Supplier Issues 15
R LinkedIn Customers Allege Company Hacked E-Mail Addresses After Work and Weekend Discussion Topics 0
S Can we be both TS16949 for Automotive Customers and ISO 9001 for other Customers IATF 16949 - Automotive Quality Systems Standard 8
K ISO 9001 vs. ISO 13485 Registration - Approximately 1/3 of our customers are medical ISO 13485:2016 - Medical Device Quality Management Systems 4
G Supplier Quality Questionnaire - Asking who our customers are Quality Manager and Management Related Issues 10
Q Internal Laboratory Services - Selling Services to "Outside" Customers General Measurement Device and Calibration Topics 1
S How to incorporate a customers special inspection frequency in our control plan FMEA and Control Plans 1
S Why do customers refuse to accept no-quotes? Manufacturing and Related Processes 25

Similar threads

Top Bottom