Medical Device Consultant, CE Mark, Gap analysis, regulatory consultant, iso 9001, medical devices, fda

Medical Device Consultant

Some of the people seeking these services already somewhat know the ropes. Because I understand this, I’ve structured this section of the website such that those that qualify in that category can skip the lengthy explanations. However, for those just starting out in the business and have little knowledge, this will give you at least a better idea of what to ask for when you contact me.

FDA inspection

Quality Systems / Compliance Audits
Design Control Services
Validation Services
Manufacturing Service Contracts
Quality Systems Creation
Training and Coaching
Other Services

a ce mark

Quality Systems/Compliance Audits

iso 9001

- Third Party Systems Audits

medical device consultant

Depending on the type and scope of the audit desired, I do on-site as well as desk audits of quality systems.

o	ISO 13485 and 9001 Compliance
	For businesses that want to get a jump-start before their Notified Body Pre-Assessment. Since notified bodies only offer pre-assessment audits for first time certification with their packages, you can use this service for compliance audits between certification audits.
o	FDA QSR Compliance
	For business done in the US, compliance to 21 CFR 820 is crucial. Although some compliance measures are not required for suppliers, there are elements of QSR that can be applied and will be helpful to your medical device customers. FDA also highly regards small firms who take the extra effort to have a third party examine their systems. ce mark This type of audit may be indicated for continuing compliance or a pre-inspection “crash” audit. I will examine your system by the same methods they do, the Quality Systems Inspection Technique, or QSIT. This can also give you an idea of what to expect when the Big Day comes.
o	Gap analysis
	How much does your organization’s quality system comply with FDA QSR? In the case of some Quality models, both established and home-grown, some do not follow the structure of FDA QSR or ISO 13485, but may or may not comply with applicable regulations. This is a necessity for OEM’s and CM’s that have only ISO 9001 or other industry certification.

medical device consultant

- Product-based audits

FDA

o	Design History Files/Design Dossiers
	At this point, this service is offered only for 510(k) or exempt devices. You would most likely want this service if you require a second set of eyes to make sure that all of your I’s are dotted and T’s crossed, or you are unsure about whether you have done too little. The point is you can never be too careful. I will scan over your records and give an assessment of where you stand with regards to applicable regulations as well as offer suggestions from the point of view of what an FDA inspector may be looking for when or if they look at your DHR.
o	Device Master Records/Technical Files
	You would want this service if you were transferring your design to production specifications. This is an important step if you are submitting a 510(k) or PMA, and there are many things you can miss. Maybe you are transferring your design to a CM and need to make sure that all elements of the DMR are properly transferred to their systems.

ASQ

- Supplier Audits

FDA isnpection

These audits are often not done or not done thoroughly by the small business. You need more than just a plant visit and a walk around to determine the suitability of the supplier. As is human nature, one will always put their best foot forward. As I have seen and heard more times than I care to mention, the best foot forward had a slight limp you didn’t notice when it came time to walk.

quality consultant

There are a few different ways to go about this service. You can have a specific supplier in mind and just want another set of eyes during the audit, I can do the audit for you if you don’t have the staff to spare, or I can set up an audit program to make sure you cover all the bases when the time comes.

medical device consultant

- Inspection/Audit support

medical devices

Picture this situation. You are sitting in your office at 8 am. You are enjoying the finest cup of coffee you could ever expect as far as office coffee is concerned, and in general you’re feeling good. 8:15 comes along and it happens. Your field office has given you five-day notification of an inspection. That coffee doesn’t taste too good right now, does it? What do we do?

a ce mark

Believe me I know this feeling all too well. I also know what it feels like to be thrown into the pit with a pack of hungry wolves after only six months with a company. See my blog for a little bit more on those experiences.

cgmp

I will help walk you through the process, and provide advice as to how to handle your inspection. My goal in this case would be to make you as comfortable with the process as possible and based on some information I would request, what kinds of questions they may ask. After the inspection I will also walk you through where you go from there to help you avoid official actions, such as Warning Letters.

asq

In the case that you do actually receive a Warning Letter, I can help you address the points cited on the Warning Letter and help you with your responses to FDA.

medical device consultant

In some cases, I can also sit second chair and coordinate responses to FDA. I would like to confine this service to existing/repeat customers, but I am willing to consider some special cases.

FDA

- Process Audits

FDA inspection

How well do your processes perform? Do they comply with applicable regulations, such as those for software validation? Are your processes properly validated? Is your process documentation adequate?

design control

I can provide answers to these questions and many more. This service might be useful if you are moving your processes to another building, adding a new process, adding equipment, changing a process or adding a new product.

risk analysis

Design Control Services

medical device consultant

NOTE: For now, all of these services will primarily be offered for FDA Class I and II devices, and MDD Class I, IIa, and IIb devices. Class III devices will be considered on a case-by-case basis.

FDA inspection

- Design History File Organization

ce mark

Maybe you have a product you want to put on the market. You’ve done testing, prototyping, and validation of your design. At the end of the day, though, you have a pile of papers and/or megabytes of information with no iota of organization and maybe you don’t even know what half of it means because it was inherited from previous management. Maybe you don’t have the manpower or the time to sort through it.

FDA

I find this to be more common than you think. The only time FDA will ever really see the whole DHF is when you are inspected. If you are beginning to realize the DHF is lacking during an inspection it’s already too late. A good DHF can mean the difference between breezing through the Design Controls Inspection process in an hour and spending days back-tracking and tracing documents, which could possibly land you a Warning Letter.

gap analysis

I can help weed through what documentation is needed from that pile of papers, put it into a presentable format, and determine if what you have is sufficient enough to say that the DHR complies with QSR and EU requirements.

asq

- Reverse Engineered Design History Files

medical devices

This service covers cases where there is no Design History File, and one must be created from scratch. Testing was done and some design controls have been applied, but may be not sufficiently documented or complete.

medical device consultant

I will get into the minds of the creators and whatever documentation you may have to construct a DHF for you.

quality audit

- Risk Analysis This is another aspect of design that is often overlooked and requires many hours of planning and meetings. I will help write ISO 14971-compliant reports, assist in the process of Risk Analysis, and bring in my experiences and thoughts to the table.

FDA

- Design Transfer

FDA inspection

At some point you will have to turn your design over to a product that can be manufactured. A DMR is in place and you are ready to go to production. There are many things that can complicate this transfer. Incomplete specifications, over-written specifications, and inadequate acceptance criteria are only a few situations I have seen.

asq

I will help you take your existing information and turn it into a DMR that will reduce your cycle time from Design Transfer to full production. I can also assist you in making your DMR and its contents more CM and supplier-friendly, so you don’t lose so much time waiting for long lead time custom parts or delays in production start-up due to lack of information.

medical devices

Validation Services

medical device consultant

- Design Validation/Verification Planning and Testing

FDA

Very simply, there is no right way to approach Design Validations. Testing laboratories are expensive, and thus complete dependence upon these labs may be cost-prohibitive. Some performance testing can be done in your facility. The key is having a good plan, writing sound protocols, and documenting the results.

gap analysis

I have a lot of experience with planning and doing validations with equipment you could buy in McMaster-Carr. I can also call upon my clinical experience to help you design performance testing that will address factors such as reasonably foreseeable abuse and potential short-comings in design. I also have lab services I can direct you to for testing you can’t do in-house. I will help write your protocols and, in some cases, actually help you perform the testing.

design history

- Process Validations

medical device consultant

Process validation is often misunderstood. If used properly, not only will it comply with applicable regulations, but it can be used as a powerful tool to boost the efficiency of your processes by reducing inspections, knowing the capability of your process before you put it into full-scale production, and give you the information you need to keep the process consistent. Suppliers especially overlook the benefits of validation.

FDA

Like design validations, process validations can be as simple or as complicated as you make them. If you make a complex or inflexible plan, you may be executing a validation where you will never meet the objectives. Make them too simple and at best you would lose the full benefit.

asq

I will review your operations and help or create a plan for validation, qualification protocols, and help interpret the results.

FDA audit

Manufacturing Service Contracts

risk analysis

FDA and EU both require that contracts for manufacturing services include sections about compliance with regulation and the roles of customer and supplier, informally known as “cGMP Contracts”. Any ambiguity will buy you a rough ride in an inspection or audit. You must also consider whether the responsibilities are assigned with all fairness and within reason for the two parties. If too much responsibility is shouldered by one of the parties, the usefulness of the contract diminishes. I can review and/or help you and/or your legal counsel compose these contracts.

FDA

Quality Systems Creation

medical device consultant

Sometimes an organization does not have a Quality System due to the fact that the company has just started doing business, there have been extensive management changes, or someone just decided to “hit the reset button” because the system has become so complex and never finished the job.

iso 9001

I can evaluate your operations and come up with solutions that suit both the regulations and your company. I will work with you to create a quality system where procedure and practice become synonymous.

FDA

Training and Coaching

medical device

You can’t change people’s attitudes and ways overnight. Being in the industry requires cooperation from the top down and everywhere in between. I offer training to management, staff, and production workers in the subjects of QSR overviews, FDA Inspection, and specific areas of compliance.

asq

This part of my services goes hand-in-hand with the philosophy that a company must be taught to fish rather than giving them meals for the day. Even if you hire me for repeat assignments, I will not be there in between jobs. Training can help you carry the torch for everything you paid your hard-earned money to buy in services from me. With my enthusiastic style of training, I can and have motivated staff and employees to support management’s decision to venture into the medical device industry, and remind management of the rewards of being in this industry.

gap analysis

Other Services

a ce mark

I believe that this is a fairly exhaustive list of the services to suit the needs of a small medical device firm or supplier to a medical device firm. As I am only human, there are probably services I forgot to put on this list or situations that I did not think of when I started this business.

iso 9001

Another part of my philosophy is that that the silliest question is the one that was never asked. If there is something in between you think you need that you see as a match for my capabilities, I would be happy to see what I can do for you. Note that I believe honesty is the best policy, and simplicity is close to godliness. I will thoroughly review your needs and see if the service is necessary for your company. If I see it in my professional opinion to be excessive, I can’t in good conscience waste your resources with unnecessary services you will have to pay for by the hour. Most likely, I will direct you to one of the established services and reassure you that any of my established services are meant to accommodate your needs.