Our Global Presence · Total Product Lifecycle Solutions from NSF Health Sciences Medical Devices...

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Total Product Lifecycle Solutions from NSF Health Sciences Medical Devices Experts in medical device quality systems, compliance, regulatory affairs, auditing and training www.nsf.org

Transcript of Our Global Presence · Total Product Lifecycle Solutions from NSF Health Sciences Medical Devices...

Total Product Lifecycle Solutions from NSF Health Sciences Medical DevicesExperts in medical device quality systems, compliance, regulatory affairs, auditing and training

www.nsf.org

Our Global Presence

For more information about NSF Health Sciences Medical Devices, contact [email protected], visit www.nsf.org/info/medicaldevices or call 1 202 822 1850.

LMD-700-0914

NSF Health Sciences LocationsNORTH AMERICA

> Ann Arbor, MI

> Bristol, CT

> Washington, DC

EUROPE

> Geneva, Switzerland

> Sheffield, UK

> York, UK

LATIN AMERICA

> Lima, Peru

ASIA

> Shanghai, China

The Right People. The Right Solution. The First Time.™

Medical device companies operate in a complex global regulatory environment

with continually changing standards. NSF Health Sciences has a team of experts in

the regulatory, scientific, analytical testing and compliance fields that understands

the industry and regulatory requirements to bring medical devices to market –

and sustain them throughout their lifecycle.

NSF Health Sciences Medical Device services can assist companies in navigating

U.S. and international regulatory hurdles from product inception through product

marketing.

Comprehensive ServicesNSF Health Sciences Medical Devices provides these services:

> Quality systems implementation, remediation, compliance and assessment

> Inspection readiness and mock audits

> Regulatory strategy / clinical support and submissions

> Corporate compliance program design, implementation and sustainment

> Training and education

NSF Health Sciences Medical Devices maintains a commitment to outstanding service and quality, and focuses on achieving the client’s business objectives through the use of sound science and expert experience. Our total product lifecycle approach allows us to provide our clients with the best solutions for their regulatory needs.

The Right People. The Right Solution. The First Time.™

NSF Health Sciences Medical Devices provides international regulatory consulting

services including FDA and EU expertise to support the development, marketing,

and stewardship of medical devices, including in vitro diagnostics and combination

products. Our core expertise is the design and implementation of successful efforts to

resolve, or avoid, challenges posed in the development of new, innovative products.

We work with a network of subject-matter experts, across all therapeutic areas, to

provide our clients with appropriate expertise in any field. In all of our assignments,

we work to balance complying with the regulatory requirements with our clients’

business needs.

For more information about NSF Health Sciences Medical Devices and our services,

please contact us at [email protected] or call +1 202 822 1850.

CONCEPT

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Comprehensive ServicesNSF Health Sciences Medical Devices provides these services:

> Quality systems implementation, remediation, compliance and assessment

> Inspection readiness and mock audits

> Regulatory strategy / clinical support and submissions

> Corporate compliance program design, implementation and sustainment

> Training and education

NSF Health Sciences Medical Devices maintains a commitment to outstanding service and quality, and focuses on achieving the client’s business objectives through the use of sound science and expert experience. Our total product lifecycle approach allows us to provide our clients with the best solutions for their regulatory needs.

The Right People. The Right Solution. The First Time.™

NSF Health Sciences Medical Devices provides international regulatory consulting

services including FDA and EU expertise to support the development, marketing,

and stewardship of medical devices, including in vitro diagnostics and combination

products. Our core expertise is the design and implementation of successful efforts to

resolve, or avoid, challenges posed in the development of new, innovative products.

We work with a network of subject-matter experts, across all therapeutic areas, to

provide our clients with appropriate expertise in any field. In all of our assignments,

we work to balance complying with the regulatory requirements with our clients’

business needs.

For more information about NSF Health Sciences Medical Devices and our services,

please contact us at [email protected] or call +1 202 822 1850.

CONCEPT

OBS

OLESC

ENCE

CO

MM

ERC

IAL

USE

MARKETING MANUFACTURING

CLINICAL

PRECLIN

ICA

L

PROTOTYPE

Bleed lineTrim

line

Comprehensive ServicesNSF Health Sciences Medical Devices provides these services:

> Quality systems implementation, remediation, compliance and assessment

> Inspection readiness and mock audits

> Regulatory strategy / clinical support and submissions

> Corporate compliance program design, implementation and sustainment

> Training and education

NSF Health Sciences Medical Devices maintains a commitment to outstanding service and quality, and focuses on achieving the client’s business objectives through the use of sound science and expert experience. Our total product lifecycle approach allows us to provide our clients with the best solutions for their regulatory needs.

The Right People. The Right Solution. The First Time.™

NSF Health Sciences Medical Devices provides international regulatory consulting

services including FDA and EU expertise to support the development, marketing,

and stewardship of medical devices, including in vitro diagnostics and combination

products. Our core expertise is the design and implementation of successful efforts to

resolve, or avoid, challenges posed in the development of new, innovative products.

We work with a network of subject-matter experts, across all therapeutic areas, to

provide our clients with appropriate expertise in any field. In all of our assignments,

we work to balance complying with the regulatory requirements with our clients’

business needs.

For more information about NSF Health Sciences Medical Devices and our services,

please contact us at [email protected] or call +1 202 822 1850.

CONCEPT

OBS

OLESC

ENCE

CO

MM

ERC

IAL

USE

MARKETING MANUFACTURING

CLINICAL

PRECLIN

ICA

L

PROTOTYPE

Bleed lineTrim

line

Total Product Lifecycle Solutions from NSF Health Sciences Medical DevicesExperts in medical device quality systems, compliance, regulatory affairs, auditing and training

www.nsf.org

Our Global Presence

For more information about NSF Health Sciences Medical Devices, contact [email protected], visit www.nsf.org/info/medicaldevices or call 1 202 822 1850.

LMD-700-0914

NSF Health Sciences LocationsNORTH AMERICA

> Ann Arbor, MI

> Bristol, CT

> Washington, DC

EUROPE

> Geneva, Switzerland

> Sheffield, UK

> York, UK

LATIN AMERICA

> Lima, Peru

ASIA

> Shanghai, China

The Right People. The Right Solution. The First Time.™

Medical device companies operate in a complex global regulatory environment

with continually changing standards. NSF Health Sciences has a team of experts in

the regulatory, scientific, analytical testing and compliance fields that understands

the industry and regulatory requirements to bring medical devices to market –

and sustain them throughout their lifecycle.

NSF Health Sciences Medical Device services can assist companies in navigating

U.S. and international regulatory hurdles from product inception through product

marketing.

Total Product Lifecycle Solutions from NSF Health Sciences Medical DevicesExperts in medical device quality systems, compliance, regulatory affairs, auditing and training

www.nsf.org

Our Global Presence

For more information about NSF Health Sciences Medical Devices, contact [email protected], visit www.nsf.org/info/medicaldevices or call 1 202 822 1850.

LMD-700-0914

NSF Health Sciences LocationsNORTH AMERICA

> Ann Arbor, MI

> Bristol, CT

> Washington, DC

EUROPE

> Geneva, Switzerland

> Sheffield, UK

> York, UK

LATIN AMERICA

> Lima, Peru

ASIA

> Shanghai, China

The Right People. The Right Solution. The First Time.™

Medical device companies operate in a complex global regulatory environment

with continually changing standards. NSF Health Sciences has a team of experts in

the regulatory, scientific, analytical testing and compliance fields that understands

the industry and regulatory requirements to bring medical devices to market –

and sustain them throughout their lifecycle.

NSF Health Sciences Medical Device services can assist companies in navigating

U.S. and international regulatory hurdles from product inception through product

marketing.