Employer Resources.

 

Operon is happy to provide the following articles, links, and resources that may be of
interest to you or relevant to your business. Check back frequently for updates.

Template Statement of Work for Medical Device & Healthcare Product Manufacturers
> Manufacturing Initiatives & Data Sources
> Industry Associations / Groups
> Training Funding & Grants
> Unemployment Data
> Industrial Safety (OSHA)
> Food & Drug Administration
> International Standards Sources
> Industry Publications
> Industry Blogs
> Made in the U.S.A, A Collection of Industry Articles
> Useful Industry Articles

Template Statement of Work for Medical Device & Healthcare Product Manufacturers

This sample statement of work is being provided as an aid to medical device and healthcare product manufacturers for the purpose of improving the effectiveness and compliance of their temporary labor procurement process.  In our world of compliance and risk management, supplier management is garnering much more focus and attention, especially in relation to the pending 2016 update to ISO 13485. This template has been vetted by veteran medtech procurement managers and should provide a good launch point for any company’s journey into this very important area of risk mitigation.

DOWNLOAD TEMPLATE

Manufacturing Initiatives & Data Sources

Resources One

A selection of resources that will keep you abreast of issues affecting your business.

Manufacturing is our future

Three million open jobs in U.S., but who’s qualified?

US Department of Commerce; Manufacturing Council
Us Dept News

Manufacturing Extension Partnership
Hollings

Advanced Manufacturing Partnership
Manufacturing

Re-shoring Initiative
Reshoring Initiative

Institute for Supply Management (ISM) Monthly Report on Manufacturing
Institute Supply Mgmnt

Massachusetts Training Fund Program
Mass Training Fund

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Industry Associations / Groups

Healthcare trade associations are a rich source of timely industry information and support. They are provided here for your convenience.

HR-BLR.com – Source for Human Resources Compliance Tools
Hr Blr

Massachusetts Medical Device Council (MassMEDIC)
Massmedic Logo

ASQ Biomedical Division
Asq Biomedical

Massachusetts Medical Device Development Center (M2D2)
Mass Medical Device

Advanced Medical Technology Association (AdvaMed)
Advamed

Medical Product Outsourcing (MPO)
Med Product Outsourcing

Medical Device Manufacturers Association (MDMA)
Mdma

Southeast Medical Device Association
semda

Medical Device Manufactures Association
mdma

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Training Funding & Grants

Training employees is a major expense. The following resources may be opportunities for you to tap into outside funding to offset some of those costs.

Massachusetts Workforce Training Fund Program
Mass Training Fund

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Unemployment Data

The following links will enable you to keep pace with the unemployment trends in your area.

Monthly Ranking by State
Bls

Yearly Trend /Comparison by State (Graphically)
Google

Economy at a Glance (Bureau of Labor Statistics)
Bls

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Industrial Safety (OSHA)

Osha
Resoources Two

Operon provides selected articles, reports and government information on employee workplace safety.

29 CFR’s; General Safety & Health Regulations

OSHA Requirements That Apply to Most General Industry Employers (What to include in your safety program!)

Top 10 most accessed Industrial standards

1. Bloodborne Pathogens – 1910.1030

2. Hazard Communication – 1910.1200

3. Respiratory Protection – 1910.134

4. Occupational Noise Exposure – 1910.95

5. Powered Industrial Trucks – 1910.178

6. Permit-required Confined Spaces – 1910.146

7. Lockout/Tagout – 1910.147

8. Hazardous Waste Operations and Emergency Response – 1910.120

9. Guarding Floor and Wall Openings and Holes – 1910.23

10. Personal Protective Equipment – 1910.132

Hearing Conversation/Program

Material (Toxic and Hazardous Substances) Safety

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Food & Drug Administration

As a regulated industry, the Healthcare Industry has many compliance rules and regulations.
Through these educational videos and regulation documents Operon hopes to make
the journey a little bit easier for you.

Fda

cGMP’s

21 CFR, Part 820, Quality Systems Regulations, Medical Device

21 CFR, Part 211, cGMP’s for Finished Pharmaceuticals

21 CFR 3.2(e), cGMP for Combination Products (Draft Guidance)

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International Standards Sources

Certifications to the International Organization for Standardization (ISO) have become the de facto tool for
organizations to communicate their practices & cultures to the world. Below, Operon has provided some quick
links to the most commonly applied documents and guidance tools for the Healthcare industry.

ISO 13485 Certification in the Staffing Industry

ISO 9000 – Quality Management System Standard

ISO 13485 – Quality Management System Standard (Medical Devices)

ISO/TR 14969 – Guidance on application of ISO 13485

ISO 14000 – Environmental Management System Standard

ISO 14644; Part-5 – Clean Room Operations & Protocols

Other ISO Standards & Industry Publications

ANSI-ASQ National Accreditation Board (ANAB)

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Industry Publications

The publications below are a partial list of sources for current information on the industry.

MassDevice
Mass Device

AdvaMed News Briefs
SmartBrief

Clinica Medtech Intelligence
Clinica

Medical Product Outsourcing (MPO)
Med Product Outsourcing

Fierce Medical Devices
Fierce Medical Devices

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Industry Blogs

Blogs can offer you an opportunity to gain fresh information and insights into the mind of
the industry, and a platform for discussions with other professionals.

The In Vivo Blog
In Vivo

Med Gadget
Med Gadget

Medical Device Daily
Med Device Daily

Device Talk
Device Talk

Shop Floor
Shop Floor

Super Factory
Super Factory

Manufacturing Business Technology

Manufacturing Biz Technology

Manufacturing Industry News
Manufacturing Industry News

Medical Product Outsourcing (MPO)
Med Product Outsourcing

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Made in the U.S.A, A Collection of Industry Articles

Reources Three

Keeping, and bringing back, manufacturing to this country are hot topics and growing trends. Read how others in business are meeting the challenges – and doing it.

Million American Jobs Project

American Made Movie
The real economic impact to our country from outsourcing
.

Retooling an Industry; MIT rolls up its sleeves <pdf>

Calculating the Total Cost of Ownership for Off-shoring Manufacturing (a practical tool) <pdf>

Improved Product Design Practices
Would Make U.S. Manufacturing More Cost Effective
<pdf>

Made in China? Not Worth the Trouble <pdf>

Some Firms Opt to Bring Manufacturing Back to U.S. <pdf>

Growing Trend in “Re-Shoring” <pdf>

http://www.areadevelopment.com/siteSelection/dec09/united-states-manufacturing-insouring-costs1102.shtml?Page=1

http://finance.yahoo.com/news/firms-opt-bring-manufacturing-back-030900792.html

http://logisticsviewpoints.com/2012/02/22/bring-manufacturing-back-to-us/


The Insourcing Boom  <pdf>

Useful Industry Articles

Contingent Labor Streamlines Manufacturing Operations
AreaDevLogo

The Risk of Using Noncompliant Temporary Labor in Medical Device Manufacturing
MPOlogo

4 Ways to Ensure Your Temp Workers Preserve Quality
QmedLogo

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