Wednesday, April 9, 2014

A First time take on the Preventive Maintenance Process

Hello All

Here is a first take on comng up with a Process of Preventive MAintenance. While the industry may be extant with method to do this, here is a grass roots level understanding of the process. I would like to hear critical comments on this from the experts.

Preventive Maintenance Process

1.        Grade all parts/subsystems based on the following 3 criteria
a.        Cost (High(>  INR25000), Medium(Between INR 25000 and 15000), Low (Less than 15000)
b.        Probability of Failure in a given period (basedon the lifetime/reliability details of the part/sub system (High(> 70%), Medium (< 70% but .> 40%), Low (< 40%)
c.        Down time for repair, rework, replacement ( High(> 3 days), Medium (Between 1 day to 3 days), Low (Less than a day)
2.        Information to populate this table should be from existing data on part failures, life time studies, reliability data, down time records etc. This may be the most important and most time consuming step in this process and requires right staff and access to the correct information.

A table with fictitious parts/subsystems for elucidating

Probability of failure
Down time for Repair/Replacement
Weighted Value- 3 months
Weighted Value- 6 months
Weighted Value- 9 months
Weighted Value- 12 months
In  first 3 months
In first 6 months
In first 9 months
In first 12 months

3.        Determine acceptable weighted Average: If there is at least 1 H or M in weighted value, that part/ subsystem shall be considered under the preventive maintenance for that particular period (Example: Part E will be considered only during the preventive maintenance during 12th month after installation since the Weighted Value has at least one M
4.        For each Preventive Maintenance session, list out the parts/sub systems that will be checked as per above table
5.        Define what constitutes “Part/subsystem is working as expected” and what constitutes “Part/subsystem not working as required”, performance creep etc.
6.        Define tests on how the part/subsystem will be checked for it fitness
7.        Define what test result would require the part to be replaced, repaired etc.
8.        Identify  measuring/monitoring subsystems requiring their calibration to be checked
9.        Define what constitutes acceptable calibration and out of calibration
10.     Define tests to check calibration status
11.     Define method to recalibrate, reverify
12.     Identify any moving subsystems that may require lubrication
13.     Identify parts requiring any specific cleaning routines
14.     Establish a Preventive maintenance plan for each device family for each subsequent preventive maintenance session (not all parts need to be checked at every session)

15.     For every installed device, establish a preventive maintenance schedule.
16.   For every PM schedule construct a proper format to capture all information without ambiguity.
17.  Train service people on what to look for during every PM visit 

Thursday, October 10, 2013

Medical Device Unique Device Identification Again

It has been months-nay- a couple of years since I actually updated myself on industry news, but UDI for medical devices is once again on the forefront I see..just read through

I am still assimilating the contents of the rule but i intend to come back here and summarise whatever I am able to put together coherently.. Watch this space for the next few days...

Friday, November 4, 2011

Medical Device QA-RA Blog from the Experts

An excellent blog from the experts on medical device regulations, Quality Assurance and related topics

It will take you a minute to create a Login Account- it is a minute well invested!!

Thursday, November 3, 2011

Overview of Route to Regulatory Compliance to For Medical Device


Writing after quite some time now!!!

I have been interacting with a friend whose organisation is developing a new medical device. A start up firm, they are keen on weaving in best practices right from start to ensure Regulatory Compliance. So I put together a small document to outline the route they could take in order to achieve that goal. I felt it was worth its while to share it here, considering that it keeps with the spirit of this blog- Quality Assurance for Novices (like me- smile)

Read on, it is pretty generic and does not cover ALL genres of medical devices (Category AP, APG, devices for Oxygen rich environments, Type A devices) but nevertheless a good start.


This write-up is intended to give an overview of the logical steps to be followed during the Product Development Cycle of a Medical Device towards compliance to international Regulatory Requirements as dictated by the applicable Harmonized Standards for medical devices.

Target Reader Profile

The target reader is expected to have a minimum knowledge of the Product Development Life-cycle, some exposure to Risk Management in Medical Device Safety, an understanding of Risk Based Device Classification and the overall requirements to compliance.

Steps to Regulatory Compliance

1. Define the “Intended Use” and “Indications for use” of your device

a. The overall device concept
b. User profile, qualification etc.
c. Location of use
d. Max. Duration of use
e. Type of contact with patient
f. Method of powering the device
g. When NOT to use the device

Refer to Note A.2.4.2 and Annexe C of the ISO 14971 standard for more eye openers on this.

This should be a working document, under document control and will form an important part of your Technical Construction File

2. Based on “1” compile complete list of applicable Harmonised standards for medical devices available at

This compiled list will be under document control and will form an important part of your Technical Construction File

3. Conduct recursive Risk analysis exercises to identify Risks arising from
a. Functional aspects
b. Electrical
c. Mechanical
d. Biocompatibility
e. Usability
f. Ingress protection
g. Software Related Failures(if your device has some form of s/w)
h. Others

Your Risk managent Procedure, Risk Management Plan for a particular family of devices, the actual Risk Management file(identification, quantification, mitigation and requantification, residual risk handling) and a final Consolidated Risk Report for quick perusal will form your risk management file.

All these to be under document control and will form an important part of your Technical Construction File

4. Based on “1”, “2” and “3” and applying the guidelines of MDD document “classification 2_2_4-1part1_07-2001” and classification 2_2_4-1part2_07-2001 Classify your device.

Generate a clear flow-chart/ table showing which rules apply and why and the final Classification.

This classification along with the rationale for classification to be under document control and will form an important part of your Technical Construction File

5. Based on ANSI/AAMI/ISO 10993 guidelines and the characteristics identified in “1” identify the applicable Biocompatibility tests for the “Applied Part”.

a. This document showing identification of applicable Biocompatible tests along with the rationale to be under document control and will form an important part of your Technical Construction File

b. Providing cross Ref. to this document, your “Purchase” document for the applied part should identify that availability of MSDS certificate from the manufacturer of the raw material of the applied part is a REQUIREMENT for accepting the produced applied parts.

6. Classify the type of Applied Part as per IEC 60601-1 definition and classification.(Your NB may perform a test on a EUT to ascertain if your classification is justified)

7. Classify your device according to ISM standards.

"Emissions requirements
Devices shall comply with the relevant requirements of CISPR 11 that contains limits and methods of measurement of electromagnetic disturbance characteristics of industrial, scientific and medical (ISM) radio frequency equipment.

ISM equipment is classified into classes and groups:

Group 1: All ISM equipment in which there is internally generated and used, conductively coupled RF energy necessary for the internal functioning of the equipment.
Group 2: All ISM equipment in which RF energy is internally generated an/or used in the form of electromagnetic radiation for the treatment of material and spark erosion equipment
Class A: Equipment is suitable for use in other than domestic establishments and those connected to the domestic power supply
Class B: Equipment is suitable for use in domestic establishments."

This forms the basis for you to identify the applicable tests for Electrical Safety in compliance to IEC 60601-1-2.

8. Complete the following tables in IEC 60601-1-2 standard.

a. Table 1 – Guidance and MANUFACTURER’S declaration – ELECTROMAGNETIC EMISSIONS – for all ME EQUIPMENT and ME SYSTEMS (Fig. 1 for guidance)

b. Table 2 – Guidance and MANUFACTURER’S declaration –electromagnetic IMMUNITY –for all ME EQUIPMENT and ME SYSTEMS (Fig. 3 for Guidance)

c. Table 3 – Guidance and MANUFACTURER’S declaration –electromagnetic IMMUNITY –for LIFE-SUPPORTING ME EQUIPMENT and ME SYSTEMS (if applicable)

d. Table 4 – Guidance and MANUFACTURER’S declaration –electromagnetic IMMUNITY –for ME EQUIPMENT and ME SYSTEMS that are not LIFE-SUPPORTING (if applicable)

Such a document with the completed tables will form the “Manufacturer’s Declaration” for the device. This will become

• a part of your final “Information to the User” documents
• The list against which your Testing Agency will perform the EMI/EMC tests.

Evidently, this will have to be under Document Control and becomes part of the Technical construction File via the IFU documents.

9. Similarly identify the applicable mechanical stability tests under IEC 60601-1 – Sec 9

10. Identify
a. The various labeling requirements per IEC 60601-1 Sec 7- specifically those required for safe installation, operation, maintenance, disposal(is any).
b. Identify the applicable symbols per EN 980 standard for medical device labeling.

Ideally there should be a working document showing what are the mandatory markings required for your device, where you intend to affix them, which EN 980 symbol(with Ref No. from the Std.) will be used etc.
This will be under Document control and will form a basis for
• Artwork for the labels
• Inclusion into the IFU to explain the various symbols found on the device to the end user.

And will be a part of your Technical Construction file

11. If your device incorporates some proprietary software, ensure that it is developed as per the ISO 62304 mandates in order to comply with IEC 60601-1-4 requirements.

a. Software Design Requirements Specification
b. Software Verification Plan
c. Software Verification Records
d. Software Validation Plan
e. Validation REcords

These will be under Document control and will be a part of your Technical Construction file

12. While designing the form factor and GUI adhere to the mandates of the IEC 60601-1-6 and maintain a working Usability File covering at a minimum the following.
a. Medical Purpose
b. Patient Population
c. Part of the body or type of tissue applied or interacted with
d. Intended Operator Profile
e. Physical Condition
f. Device Mobility
g. Primary Operating Functions (Critical, Frequently used, sparingly used)
h. Use Cases (what constitutes Pass and Failed use case)
i. Interface Requirements between user and device- GUI elements, alarms, annunciations, labels etc.
j. Safety information to be provided- symbols, labels, messages, warnings etc. On Device, in IFU etc. (ideally with ref. to the Risk management file where these needs have been identified), the symbol reference from the applicable standard etc.
k. Operator- User Interface Requirement Verification Checklist
l. Usability validation plan
m. Records of Usability Validation

These will be under Document control and will be a part of your Technical Construction file.

13. The requirements for Electrical safety, Mechanical safety and Biocompatibility identified under “5”, “6”, “7”, “8”, “9” should go into your DRS with some traceability from the DRS to those documents and if feasible- to the Risk File.

14. The Labeling and IFU requirements should be verified as fulfilled in a Review of the IFU and final Labeling of the device. An IFU validation Plan and associated records will ensure a good IFU quality

15. Clinical Evaluations/tests to prove the efficiency of the device should be performed as per ISO 14155 requirements. There should be
a. A Clinical Evaluation Plan
b. A roadmap of the Execution of such plan
c. Records of the evaluation
d. Final inferences drawn and conclusion of the Evaluations

16. It would be a good practice to populate the “Essential Requirements Checklist under MDD 93/42/EEC and do multiple reviews to ensure all requirements have been met.

17. MOST IMPORTANT- All documents to be under Document controls, dated, reviewed and cleared as Final and Acceptable for Release.


This exercise would cover a good part of the REgulatory requirements for most regulatory approvals.

Remember this is only the ground work. Your actual design phase will incorporate the requirements you identified through this exercise. But you have the edge that you will not have to recursively repeat your design phase after finding that your design is non compliant as is the case when you do not identify the regulatory requirements early on. This reduces the time to market as also the astronomical costs associated with redegisning.

Do write in with your comments on whether at all you find this article useful. Good Day!!!

Friday, August 6, 2010

Translation of Medical Device Documentation

Found this EXTREMELY USEFUL article on translation of medical device documentation on MDDIONLINE and wanted to share it on my blog..

Have YOU factored in translationexpenses into your bugdet yet?!!

Thursday, July 1, 2010

Supplier QA- Why is it so difficult for startups??

Having worked for start up organizations, I have observed a certain level of difficulty when it comes to complying with supplier Quality Assurance.

supplier QA typically should follow the following flow:

1. Come up with a complete specification of the product/service to be sourced
2. Scout for vendors/suppliers/sub contractors (V/S/SC)in the market who provide the specified product/service
3. If monopoly supplier/vendor, no questions asked- Go with it
4. Else: Evaluate the prospective V/S/SC against a list of requirements- some requirements may be generic, others may be specific to the product/service (For Example- being compliant to a particular standard)
5. If the V/S/SC passes the evaluation, add the V/S/SC to a master list of Approved Supplier/Vendor
6. Before finalising a purchase/contractual agreement etc. provide in black and white the Quality Requirements to be met by the V/S/SC (Provide a QA certificate for every consignment, provide COC for every batch and so on)and the consequence of quality lapses (return of goods, revoking the agreement and so on)
7. Schedule periodic re-evaluations and re-evaluations based on certain triggers (repeated quality problems- non conforming goods supplied, delay in shipment, wrong product sent etc. )
8. Always select V/S/SC from the approved supplier list

For a start up which does not have an experienced top level management which is particular about QA and has factored in supplier QA at some early stage of product develeopment planning the following is what normally happens:

As with all new products, the early stages of building proof of concept, prototyping and the first few production unit equivalents are built and tested before final production. The early stage product require the same (or near same) components, and these components are ordered in very few numbers at this stage.

At this stage only Step 1 of the above list is executed. The goal at this point is to obtain the components in very small quantities, at the most competitive price (we are talking start up). What happens is that the start up ends up assuring the V/S/SC of bulk purchase once production kicks in and thus try to get a good price.. For custom products, they may approach small time suppliers since their overhead would be the minimum and would drive the price down for the "few" units they need

In the meanwhile, nobody executed step 4/5 - nobody scouted for alternative sources or evaluated them.. So when the "Production units" stage is reached, the start up is stuck with the V/S/SC who provided the early stage supplies...

And at this stage the company is thinking QA/ ISO 9001 certification (at a minimum) to boost their market image (really- they weren't looking for process based functioning- I promise you!!!) and then the problem starts-

ISo 9001 wants you to select the supplier based on his ability to supply the goods your product requires, requires you to control the purchase product, requires you to monitor incoming goods, requires YOu to control the outsourced process.

Having given the supplier a free run in a state of " we cannot exist without you" it now becomes difficult to require the supplier to adhere to YOUR requirements-

1. You ask for material specifications- Supplier says My way or the Highway
2. You ask for QA Ok certificate- Supplier says- My product never failed in all these years how can you insult me!!!
3. You ask for equipment validation to be done - Supplier says Equipment "What???"

If the V/S/SC is a willing candidate to aid your QA effort although he it also start up- I should say you are blessed- this way the supplier gets better as you get better...

And this is the crux of the matter- Explaining to your supplier your QA requirements, explaining the role he plays in the larger scheme of your adherence to quality and his contribution. If you could achieve this, nothing like it..

But how many start ups have the time and means to have such a symbiotic relationship with the supplier???

Tuesday, June 8, 2010

Control Of Non- Conforming Product- An FDA Vs. MDD/13485 Perspective

I found this very very useful link, which discusses "Control Of Non Conforming Product" in the light of FDA's QSR, MDD/ISO 13485- it brought in quite a bit of clarity to me.. Hope more novices find use in it!!