The Device History Record (DHR)

The Device History Record (DHR)

The US FDA states the following:

Each manufacturer should maintain DHR’s. For what steps in the manufacturing process are these records to be maintained? It is for establishing and maintaining procedures to ensure that DHR’s for each batch, lot, or unit. The purpose of this requirement is to show that the medical device is manufactured exactly as mentioned in the DMR and that the requirements are met. The FDA states that the DHR shall have in it, or will refer to where it locates these bits of information:

  • the manufacturedates
  • the manufacturedquantity
  • how much quantity was released for distribution
  • records showing acceptance that the device is manufactured in accordance with the DMR
  • the product’s primary identification label and labeling that went into each production unit; and
  • detail of all and any device identification(s) and control number(s) used in the manufacture of the device.

Important facts to remember about the DHR

It is not mandatory to keep the original DHR with the device. It is possible that due to frequent testing and other tasks carried out; the DHR can get tampered. However, before any DHR is removed, there should be a sound set of controls to retain or retrieve data. It should be kept intact, so that there is no loss of record. An authentic way of ensuring this is by having a person in the organization in charge of this aspect. That person can scan the DHR and store it into a repository.

A device that goes into distribution with a DHR is as considered a spurious one. Anyone responsible for doing this is liable for a year’s imprisonment or a penalty of up to $1000.

The manufacturer should ensure clarity on whether the product has an original DHR or the record of a rework. Rework in this case refers to the changes done on a nonconforming product to meet regulatory requirements.

On the other hand, alteration is the repair or servicing carried out on a product that has already entered distribution.

Finally, remanufacturing is the process carried out on a conforming product to make it nonconforming. Also included under this is anything that is done to the device to alter its characteristics. All these three types of work on the device should be recorded in the DHR and maintained.



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QBD Analytical Method

QBD Analytical Method

ICH Q8 (R2) describes the nature of Quality by Design (QBD). QBD is a systematic approach to pharmaceutical manufacturing and development. Based on exact science with incontrovertible evidence, QBD aims at bringing about product and process understanding and process control. QBD seeks to bring all these about by beginning with predefined objectives.


The flow of processes in a QBD approach would typically be thus:

  1. selecting the product profile
  2. defining the critical quality attributes (CQA)
  3. performing risk assessment by linking raw material attributes and process parameters to CQAs
  4. cultivating a space for design
  5. arriving at a control strategy
  6. accomplishing product lifecycle by making continual development an integral part of it.

Analytical methods used in QBD

Both analytical and advanced analytical methods are used in QBD to achieve the end result of product and process development.

Analytical methods:In using analytical methods, QBD makes use of measurement of Critical Quality Attributes of everything relating to the product –the raw materials, intermediaries and the final product. Secondly, it supports risk assessment based on these qualities.

Advanced analytical methods: In order to achieve and enhance greater manufacturing control, a QBD uses analytical methods, which form the basis of Process Analytical Technology (PAT) and Real Time Release Testing (RTRT). This is done for process monitoring and for achieving continual improvement.

What purpose do these analytical methods achieve?

Precise analytical methods help achieve the following:

  • they help aggregate the selected product profile
  • they enable exact measurement of product CQAs and the intermediaries used in the process
  • they help identify and fix measurements and controls used in the process
  • they provide inputs with which to track and trend processes, leading to continual improvement in the process and the product.



OHSAS 18001 Gap Analysis Audit

OHSAS 18001 Gap Analysis Audit

OSHA stands for Occupational Safety and Health Administration. OSHA 18001 is the international standard that ensures safety and health at the workplace. It is the organization that has to show compliance with the provisions set out in this standard by ensuring that it is implementing OSHA 18001 at its workplace.

The aim of carrying out OSHA 18001 is to ensure that there is good management of work-related safety and ergonomics at the workplace. It seeks to reduce accidents and work-related health issues.

What is the role of gap analysis?

Gap analysis is all about determining if the organization’s safety management systems sit in sync with the requirements set out in OSHA 18001. Like all other gap analyses; OSHA 18001 gap analysis audit too, should be done before an organization puts its safety system in place. This is because of the obvious reason that it makes sense to carry this out at an earlier stage than later.

The aim of the gap analysis is to prevent future gaps and maladjustments into the organization’s safety systems. Carrying out this audit is also helpful in identifying areas of safety that matter most to employees, gauge the resources needed for carrying this out, and acting on these.

Documentation is at the heart

When an OSHA auditor visits your place, make sure that your documents on safety are in place. Make sure you have all the details they will ask for, such as the number of employees in the workplace; safety measures in place till now; the number, if any, of employees with physical challenges, and what has been done to address them, and the like.



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ISO 13485 vs. ISO 9001

ISO 13485 vs. ISO 9001

One of the most commonly countered questions in the medical device industry is: ISO 13485 vs. ISO 9001. They are often confused for each other. But they are never the same, although they have many common requirements.

ISO 13485 is part of ISO 9001 family of regulations

When understanding ISO 13485 vs. ISO 9001, we have to understand that both standards are part of the ISO QMS, and must meet general requirements. These general requirements merely state that “the organization shall establish, document, implement and maintain a quality management system and maintain its effectiveness in accordance with the requirements of this International Standard”.

ISO 13485 flows from ISO 9001. While ISO 9001 is a general standard for third party assessment, ISO 13485 is that part of this standard that is specific to the medical devices industry.

Critical differences

The crux of ISO 13485 vs. ISO 9001 lies in the application. ISO 13485 includes some specific requirements for medical devices and excludes those requirements of ISO 9001 that are not appropriate for regulatory requirements. So, although similar on the surface, these two standards work in tandem, but are yet exclusive to each other in many respects.  Organizations which claim that their medical devices meet ISO 13485 requirements cannot claim that their organization automatically meet ISO 9001 as well.

The ISO wanted to make the 13485 specific to the medical devices industry. It wanted to remove the complexity associated with the 9001 and make a standard that was usable by organizations of varying sizes, was easily comprehended, was compatible with management systems such as ISO 14001, and had a direct relationship with the activities that went into running a business. The ISO 13485 standard has achieved all this, and thus is a continuum of the ISO 9001 standard with the necessary refinements.

Difference in terms of operation

ISO 13485 must define document retention times based on organizational and regulatory requirements, while 9001 must record retention times based on organizational and regulatory requirements.



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ISO 13485 internal audit

ISO 13485 internal audit

So, you are in the medical devices industry, and one of the first items you would come across in your profession is having to deal with an ISO 13485 audit. What is the ISO 13485, and what does it take to audit it?

Understanding the ISO 13485

First things first. Let us get to the root of the matter: What is ISO 13485? The ISO describes the ISO 13485 thus:

“ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services”.Thus, it is clear that ISO 13485 concerns itself with regulatory requirements for QMS.

Does my organization need an independent auditor for ISO 13485?

ISO 13485 requires many important parts. Some of these are:

  • Compliance Audit Program
  • Policy Audit Program
  • Procedures Audit Program
  • Process Audit Program
  • Records Audit Program

What is given here is only a small sample of the parts required to be audited. Come to think of it: Would your organization have the time or resources to implement these complex audits? Being in the medical device industry is strenuous to say the least. On top of it, apart from having to work on your core business, do you think it is wise to allocate resources for intricate tasks such as audits?

Think of having an independent organization/auditing company/individual who will be dedicated for this exclusive task. Does it not make your task easy and efficient?


ISO 13485 Gap Analysis

ISO 13485 Gap Analysis

Gap analysis is an important aspect of the ISO 13485 audit. The ISO 13485 standard lists out requirements for a wide-ranging management system for the manufacture and design of medical devices. When a medical device organization performs a gap analysis, it is analyzing the gaps that exist in its QMS vis-à-vis that prescribed in ISO 13485.

Why do the gap analysis?

Performing the gap analysis is obviously of very high importance to a medical device company. It helps the business understand the shortfall it has in relation to meeting regulatory requirements set out by ISO 13485. It helps it identify areas of insufficiency.

When should it be done?

It is best advised that organizations carry out the gap analysis before its final QMS is put in place, because identifying gaps at this stage is prudent. When carried out at this stage, it saves resources and time by nipping in the bud issues that could pile up later on. When gap analysis is not done at this stage, it becomes difficult to implement a QMS. As the old saying goes, a stitch in time saves nine!

How to do it?

It is always a great idea to get an ISO consultant to perform your organization’s gap analysis, because the professional knows best. By dedicating that person for this task, you could not only get a neat job done; you could also save on time and your own company resources.

Performing the gap analysis requires answering a set of questions relating to the QMS. The consultant will frame a set of questions that he/she will get you to answer. Some of these questions typically are of this nature:

  • Has the requirement been met?
  • Has the gap been identified?
  • Has remedial action been taken, or is it not necessary?

If the answer is “no” to any of these, it means that further action is necessitated. Leaving your ISO 1385 gap analysis to an expert requires your active support and cooperation.

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The Device Master Record (DMR)

The Device Master Record (DMR)

The Device Master Record (DMR) is what may be described as the complete documentation required in the manufacture of medical devices that meet quality standards. The DMR, along with the Device History Record (DHR), is an extremely important element of the Quality System Regulation (QSR) in relation to FDA cGMP.

Inputs and final product

The DMR constitutes the raw ingredients of the QSR. It is what goes into the QSR, while the DHR shows how these ingredients worked to deliver the final product. It needs to come with a Standard Operating Procedure (SOP), which defines the exact contents of the DMR, which will pave the way for the creation of an SOP for DHR, as well. One of the primary uses of a DMR is that being a master record; it tells employees the specific functions that need to be performed in the manufacture of a particular medical device.

No hard and fast rule about arrangement

Section 820.181 of the FDA spells out the requirements for DMR. A very important component of this section is that it does not make the type of arrangement of information about the device watertight. It gives sufficient freedom to manufacturers of medical device in that they are free to write information about it in any manner they like, so long as it is easily accessible.

Device specification –the core of the DMR

The foundation or what may be called the preface to the contents of the DMR is device specification. This section of the DMR briefly lists out all important details of the external nature of the device. Usually, a DMR device specification has the following:

  • the device’s product trade and common name(s)
  • intended use(s)
  • environmental limitations and product stability
  • important components and formula (if applicable)
  • performance characteristics and theory of operation
  • physical characteristics
  • regulatory classification
  • user safety characteristics.



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USP 1225

USP 1225

Quality levels of pharmaceutical items are set out in various test procedures and instruments. US pharmacopeia, which deals with specifications of drugs and other pharmaceutical products, uses the following criteria to assess the method validation of these products:

  • accuracy
  • precision
  • specificity
  • detection limit
  • quantitation limit
  • linearity
  • range
  • robustness

Types of test methods

USP 1225 establishes the types of test methods. These are:

  • assay
  • identification
  • testing for impurities – quantitative
  • testing for impurities – limit
  • performance

Specificities of USP 1225

Failure to meet regulatory expectationsunder USP 1225 typically invites statements such as “Failure to establish accuracy, sensitivity, specificity, and reproducibility of test methods employed by your firm”, which will be the explanation the FDA gives for failure of compliance, leading to the issuance of a 483. Such an observation reflects the lack of understanding of the nuances of method validation on the part of the analyst.

The way out

Test methods that meet USP standards are essentially about common sense. The analyst has to understand and identify the foundational aspect of test validation –the intended use of the test method. This is what enables her to categorize the test method into one of the types prescribed by the USP. This will be the gateway to a clearer understanding of the guidance set out in USP 1225. This is because the underlying matter is that the analyst must prove that the method performs exactly as intended. This is what forms the basis of the above criteria and test methods.



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ISO 14001 –the management’s responsibilities

ISO 14001 –the management’s responsibilities

ISO 14001 deals with an organization’s environmental policy.  This instrument has been designed to ensure that organizations achieve and demonstrate sound environmental performance. An organization has to assess the impact of its business on the environment and shape its environmental policy accordingly, so that it contributes to sustainable development.

Management’s role

The management in an organization is the prime player in implementing environmental actions laid out by ISO 14001. Many of them undertake their own environmental performance and audits, but they have to be consistent with what is required of this standard. This ISO standard requires that organizations implement an Environmental Management System (EMS). It requires the organization’s top management to define and enforce the organization’s EMS. The most important points of this policy are that the organization should have an EMS that reflects the nature of its products and is appropriate and proportionate to them and that there is transparency in the policy, meaning that it is made public.

Implementation and operation

In implementing its EMS; the organization should designate a person who will oversee the policy. The environmental policy should be implemented on the organization’s infrastructure, such as buildings, its facilities, drainage tanks and so on.

The organization will appoint a competent, knowledgeable person who has the skill, knowledge and experience to carry out this policy. They could also be trained for the purpose of carrying out the organization’s EMS.

Transparency and introspection

It is very important for the organization to ensure transparency in its policy by internally communicating the goals and objectives of the policy to all employees. It should document every action it takes on the EMS by constantly evaluating the impact of its actions in relation to the environment. It should analyze this in relation to the impact of what its non-actions will have on the environment. It should also make adequate responses to onsite emergencies such as proper storage of inflammable materials.



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Aspects to look out for in your ISO 13485 Quality Manual

Aspects to look out for in your ISO 13485 Quality Manual

Each and every organization that implements ISO 13485, an important ISO standard, has to have a Quality Manualin place. The ISO 13485 sets out requirements for a complete management system for organizations that are in the business of designing and manufacturing of medical devices.

Since ISO is essentially about documentation; a medical device company’s objectives must be clearly defined and documented in its Quality Manual. ISO 13485 states that a Quality Manual must be created and maintained. Three very critical aspects need to be documented:

  • procedural requirements
  • planning, operation and control of processes
  • records that are required to comply with the ISO 13485 Standard

Management Commitment and Responsibility

As part of ISO 13485, a medical device company’s management is responsible for implementing an effectiveQuality Management System (QMS). This, along with its commitment to enforce it, should be part of the Quality Manual. The Quality Manual should reflect commitments of the Quality Policy, which should be on these lines:

It should establish aQuality Policy. This policy should reflectthe purposes of the organization and should be aligned to it.

The Quality Policy must make sure that the organization’s quality objectives are established and adhered to.

The management should periodically conduct management reviews.

It should ensure that resources are made available for this work.

It should meet customer requirements.

Management should identify, document and communicate to the rest of the organization the responsibility and authority to define, implement and monitor processes.

Management has to appoint a representative whowill be assigned the oversight of creating awareness of customer requirements. This representative should also ensure that the processes needed to implement and maintain aQMS are put in place and maintained.

Management should take every step towards facilitating internal communication.

One of the most important tasks for the management is to review the QMS to ensure that it is suitable, adequate and effective. This review is based on a number of parameters, the most important of which are feedback, process performance and product conformity. It should also ensure CAPA.


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Phone: 800-447-9407
Fax: 302-288-6884

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