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

Medical Device Consultant

DISCLAIMER: This list of terms and conditions do not by any means constitute the entire text of a contract.

ISO 9001

1. Conflict of interest

FDA audit

Consulting for me is a part-time job. I am employed full-time at Ansen Corporation in Ogdensburg, NY as a Quality/Regulatory Engineer. As such, I must be aware of the potential conflicts of interest that may present themselves. All these rules also apply for jobs obtained through my partnerships with other consulting firms and through my employer. Here are my rules:

fda inspection

a.	I cannot perform any services for Contract Electronic Manufacturers. The reason for this is I work for a CEM and you would most likely be one of our competitors;
b.	I cannot perform quality systems auditing services for any current suppliers of Ansen Corporation. I work with our purchasing department in order to audit our suppliers. It would not be fair to you to pay for services that are already a part of my job and advantages you get from getting these audits as an Ansen supplier;
c.	As I cannot foresee all conflicts of interest, potential conflicts will be determined for all would be clients. In the case there is a perceived conflict of interest, you will be informed immediately. Wherever possible, I will also refer you to other consultants that can assist you with your needs.

ce mark

2. Liability

medical device consultant

Unless otherwise stated by contract, all improvements or changes resulting from my services are recommendations only. It is the responsibility of the client to decide what course of action to take as a result of my execution of services.

ISO 9001

In situations where I am obligated by contract to sign any document created or reviewed by me, the client is responsible for reviewing and countersigning said documents. Unless otherwise stated by contract, should the client not accept these terms, I reserve the right to terminate any service without refund.

asq

3. Discovery and Due Diligence

medical device

By law and certain Codes of Ethics I am bound to, I am required to report the discovery of any conditions where intentional or malicious illicit act(s) exist found in the course of performing services for a client, whether facilitated by management or not. The client will be given an opportunity to correct the condition during which time my services will be suspended. If the condition is not corrected within a reasonable time frame from the time of discovery, the appropriate authorities will be informed and my contract with the client shall be terminated immediately without refund.

gap analysis

4. Litigation and Jurisdiction

medical device consultant

My business resides within the State of New York. Any disputes or arbitration with regards to services rendered shall be under the jurisdiction of the laws of New York State.

ISO 9001

5. Intellectual Property and Confidentiality

ce mark

With the exception of certain standardized training and documentation templates used as the basis for services rendered, all outputs of services rendered shall be the sole property of the client.

fda inspection

As the sole proprietor of this company, I am in the capacity to sign a confidentiality agreement. If the client lacks documentation of a confidentiality agreement, one will be provided.

regulatory consultant

If my services are used through one of my partners, the confidentiality agreement signed through them supersedes any previously signed confidentiality agreements between me and the client.

medical device consultant

6. FDA Inspection, Responses, and Coordination

a ce mark

Full disclosure of all information pertinent to an inspection or subsequent response to findings or actions is expected of the client. Like a lawyer, I cannot be an advocate if you don’t tell me everything I need to know, no matter how unpleasant.

risk analysis

All written and verbal responses to FDA through me must be approved by the client. Wherever practical, the client will be asked to countersign or be present during any communication with FDA. Any actions stated in such communications are the responsibility of the customer unless said actions are included as part of a service contract.

ISO 9001

I assume no liability for official actions imposed by FDA for services not rendered or courses of action that were recommended but not taken.

fda inspection

7. Payment/Pricing

medical device

Sometimes there is ambiguity as to what “billable hours” means from consultant to consultant. In my case, billable hours will include any actual evaluation, documentation, or activities pertaining to the executed contract. Phone/Conference calls, e-mails with clients, and conversations during allotted mealtimes or other such breaks (e.g., if a customer takes me out for a couple of rounds of golf) are not considered billable hours.

medical device consultant

I consider these forms of communication customer service and time used to build a relationship with a client. You should not be made to pay for every minute of time I spend communicating with you just so that I can make an extra buck.

asq

I reserve the right to change my hourly rate at any time during my business relationship with the client.

ISO 9001

The client understands that there may be unforeseeable circumstances and situations that are discovered in the course of rendering services. If this is the case, any amendments of the quoted price shall be submitted to the client in itemized format with justification prior to additional services being rendered. The client shall then be given the opportunity to approve or disapprove the additional work.

a ce mark

If my services are retained through any of my partners, rates are to be determined by that partner. Additionally the client will be bound by the agreement of the partner for terms of payment.

medical device consultant

It can get expensive to do onsite visits. As such, it’s only fair that coverage of this all-important subject find its way into this section. Travel and expenses will be addressed on a case-by-case basis. If my services are rendered through one of my partnerships, they will determine how T&E will be handled. In general, the client should either pay for at least airfare and accommodations directly on my behalf, or pay me up front such that I can cover those expenses. Rental cars and meals can be fronted by me and reimbursed when we meet. In general I would like to get that reimbursement within a week of my return from your visit.

risk analysis

I require a retainer for my services in the amount of 10% the quoted price of services. My terms are net 30 days from the date of completion of services for the balance unless otherwise arranged by contract. If payment is not received in 90 days, unless arrangements for payment are made, I reserve the right to pursue legal action against the client to recover my fees. The business relationship shall also be immediately terminated, and any additional quotes issued within the 90 days become null and void.

medical device consultant

8. Unforeseeable Events or Cancellation of Services

ISO 9001

If services cannot be rendered due to Acts of God or other unforeseeable events, the client may reschedule said services for another date at no charge. The client only agrees to pay any fees as they pertain to rescheduling of travel arrangements if such fees will exceed the cost of the retainer.

ce mark

In the case that the client cancels the contract for any reason prior to any services being rendered, the client will be refunded their retainer. In the case that partial services are rendered, the client will be responsible for paying for services rendered and the retainer will not be refunded.