Keystone Regulatory Services, LLC

Useful Links

The following list of links may be helpful for the medical device manufacturer.  Topics include regulations, standards organization, professional organizations and others.  Check back often as more links are added.  To report a dead link, please click here.

Phone:     717-656-9656

Fax:         717-656-3434

E-mail:     bill.mclain@keystoneregulatory.com

To contact us:

342 E. Main St.

Suite 211

Leola, PA 17540

Consulting Firms

While we hope we can meet your regulatory and QMS consulting needs, we are pleased to recommend several excellent consultants supporting the industry.

· The CRO Group

· RA/QA International

· Reilly and Associates

· AlvaMed

· Quality Management International

· MDCI, Inc.

· Emergo Group, Inc.

 

Regulations:

· Title 21 Code of Federal Regulations

· Medical Device Directive (93/42/EEC) Text

· In Vitro Diagnostic Medical Device Directive (98/79/EC) Text

· Directive as regards medical devices incorporating stable derivates of human blood or human plasma (2000/70/EC)

 

Notified Bodies:

· List of Notified Bodies

· KEMA

· TÜV Rhineland

· NSAI (National Standards Authority of Ireland)

· TÜV SÜD

· BSI

 

Standards and Guidances:

· FDA Recognized Consensus Standards Database

· List of Harmonized Standards

· Global Harmonization Task Force

· International Organization for Standardization

 

Professional Societies:

· Regulatory Affairs Professional Society

· American Society for Quality

· ASQ Philadelphia

· ASQ Biomedical

 

Medical Device Testing:

· CITECH—Mechanical and electrical safety and performance testing.

 

Presentations:

· ASQ Philadelphia Early Bird—February 16, 2005