Blog

News

What Data Integrity Means to Device Manufacturers

August 28th, 2015 by

Data SecurityData integrity is an ever-increasing concern in life sciences, with medical device manufacturers feeling much of the conformity backlash. There continues to be heightened regulatory focus on diverse cybersecurity topics, including data integrity.

Public and private sector organizations [...] Read More

Outsourcing and the Device Manufacturer’s QMS Accountability

August 6th, 2015 by

Global Medical Technology ComplianceIn 2003, the International Organization for Standardization (ISO) issued ISO 13485, officially known as EN ISO 13485:2003. This voluntary international standard provides a framework to assist medical [...] Read More

A Flexible Approach to 21 CFR 820 Compliance

June 11th, 2015 by

Medical Device ComplianceThe Quality Systems (QS) Regulations of FDA 21 CFR 820 are general standards that apply to finished devices, that are intended for human use.. Rather than impose strict requirements, the regulations offer manufacturers of these devices an opportunity to [...] Read More

Will 21 CFR 11 Hinder My Compliance Efforts?

March 31st, 2015 by

Electronic Records ManagementElectronic records are complex by nature. While they ostensibly serve as evidence of compliance efforts and regulatory adherence, [...] Read More

Choosing the Most Effective IT Infrastructure Qualification Strategies

January 27th, 2015 by

IT Infrastructure Qualification Strategies[...] Read More

Meeting Compliance Goals With Deviation Management And CAPA Systems

June 2nd, 2014 by

Deviation ManagementYour firm will experience compliance failures from time to time. In the realm of complex GxP-regulated processes, like automated pharmaceutical manufacturing and medical device quality assurance, things can go wrong with little advance warning.

While it would be nice to prevent such issues [...] Read More

Can Medical Device Compliance Consulting Benefit You?

April 29th, 2014 by

Compliance ConsultingAs all medical device manufacturers know, life sciences firms are bound by GxP rules and recommendations. Firms that want to create and maintain marketable product lines must be willing to subject themselves to intense regulatory scrutiny. They also have to comply with a range of rules pertaining [...] Read More

Quantifying The Value Of An FDA Mock Audit For Medical Device Manufacturers

March 21st, 2014 by

FDA Mock AuditFDA and ISO inspections are extremely stressful, but they play vital roles in your market viability. Even if you [...] Read More

Using Audits To Improve Your Supplier Quality And Performance

March 19th, 2014 by

Supplier AuditsSupplier oversight and quality is imperative in maintaining the integrity of your product as well as your brand. When done correctly by knowledgeable and experienced consultants, [...] Read More

FDA Demands Full Compliance With GMP Requirements in the Pharmaceutical Industry – To What Extent Is Compliance Required?

March 12th, 2014 by

Pharmaceutical Production ComplianceThe most succinct answer to the question of what determines FDA compliance with GMP regulations of pharmaceutical production is adherence to 21 CFR Part 210 and 211. Anything less than complete adherence will render [...] Read More